Susan Haigney

Regulatory Roundup—August 2026

In August 2026, a new FDA commissioner was nominated by the White House; there was a variety of novel drug approvals spanning oncology to narcolepsy; and parallel moves from the United Kingdom's MHRA and Europe's EDQM were made to modernize standards—all set against tightened manufacturing scrutiny on both sides of the Atlantic.

On August 19, 2026, the White House nominated 

 a physician with a Johns Hopkins doctorate and prior roles at the White House Domestic Policy Council and the America First Policy Institute, to fill the permanent FDA commissioner post left vacant since 

, after Acting Commissioner Kyle Diamantas reportedly turned the job down more than once. The nomination arrives as FDA works through a roughly 20% staffing reduction, and Senate confirmation is not guaranteed.

The White House announced what it called the 

largest annual drop in prescription drug prices in more than 60 years

 The administration credits Most Favored Nation pricing deals with 17 manufacturers covering roughly 86% of the branded market, alongside the TrumpRx platform (cited as generating $700 million in patient savings) and GLP-1 prices falling from over $1000 a month to as low as $149. The release reports prescription drug prices down 3.9% since the administration began and falling every month in 2026, with the Department of Veterans Affairs citing $10 billion in pharmaceutical savings for the fiscal year.

, spanning oncology, immunology, infectious disease, and rare genetic disorders.

 Several of these were approved in August.

In oncology, the FDA granted accelerated approval to Replimune's Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for 

 that has progressed on PD-1 therapy, a population where, as IGNYTE study investigator Michael Wong noted, patients “have few options after anti-PD-1 therapy and face high morbidity.”

 put the objective response rate at 24.2% among 91 evaluable patients, with a median duration of response of 14.1 months; confirmatory trials are required to maintain approval.

 as the first RAS-targeted therapy for metastatic pancreatic adenocarcinoma, arriving 6.5 months ahead of schedule after a 500-patient trial showed median overall survival of 13.2 months versus 6.7 months on chemotherapy. Center of Excellence Director, Angelo de Claro, called the results “unprecedented” for an area of high unmet need.

Bristol-Myers Squibb also picked up accelerated approval for 

 in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for relapsed/refractory multiple myeloma, based on EXCALIBER-RRMM data showing a 41% MRD-negative complete response rate versus 21% for the comparator arm; the drug carries boxed warnings and restricted REMS distribution given embryo-fetal toxicity risk.

Neurology and infectious disease also saw approvals for new drugs. The FDA approved 

, the first orex in receptor agonist for narcolepsy type 1, which the Center for Drug Evaluation and Research (CDER) Psychiatry Division Director Tiffany Farchione described as “the first medicine that impacts the underlying biology of the disease.”

, a tau PET imaging agent that Massachusetts General Hospital's Keith Johnson said is “essential for increasing our understanding of potential disease impacts” in Alzheimer's evaluation, though the approval excludes non-Alzheimer's tauopathies.

, the first messenger RNA-based flu vaccine, for adults 50 and older, contingent on a confirmatory trial in the oldest cohort, after a 40,000-plus-participant trial showed roughly 27% higher effectiveness than a standard-dose comparator.

 from birth through four weeks based on the IMPAACT 2023 study,

 as the first oral therapy for adult dermatomyositis, which FDA's Nikolay Nikolov said is “giving patients and their healthcare providers an approved oral therapy.”

 new drug application for pediatric Tourette syndrome was accepted with priority review, targeting an action date in early 2027; EVP Eric Hughes called it potentially “the first novel mechanism of action in more than 50 years” for the condition.

The FDA also moved on several policy fronts. A 

draft revision on choosing between an abbreviated new drug application and a 505(b)(2) application

 is open for comment through October 19, updating 2019 guidance on the same question.

draft guidance on container closure systems

 for human drugs and biologics, including combination product components is open for comment through October 13.

"What stands out in the draft guidance is the emphasis on understanding container closure integrity as part of the overall manufacturing process rather than as a standalone compliance exercise. For sterile drugs and biologics, especially in high-value injectable formats, manufacturers need reliable ways to detect defects that may compromise package integrity before products reach patients. Technologies such as automated vision inspection and deterministic CCIT methods can provide a deeper understanding of process performance, helping manufacturers move from reactive testing toward real process control. That's where we see the industry heading, and the guidance aligns well with that direction," Daniele Ansaldi, Technical Manager, Inspection Machines for Antares Vision Group, told 

And Deborah Smook, VP of Marketing & Business Development for TurboFil Packaging Machines LLC, provided her take on the guidance, telling 

: “FDA’s new draft guidance updates container closure recommendations that have been in place for more than 25 years, reflecting advances in drug-delivery systems, combination products, materials science, and testing. Of particular relevance to equipment manufacturers such as TurboFil, the updated guidance places more explicit emphasis on how manufacturing and assembly processes can affect container closure integrity and device performance, including the control and validation of parameters such as capping, stoppering, and other closure operations. We believe this reinforces the value of involving filling and assembly equipment suppliers early in product development, when component specifications, tolerances and critical process parameters can be addressed before the manufacturing process is finalized.”

potency assessment standards for active immunotherapy products

, supplementing 2023 guidance on cellular and gene therapies, with comments due November 18, 2026.

 tied to injectable glutathione made with dietary-supplement-grade material from a single lot, prompting recalls at two Texas pharmacies and a reminder that supplement-grade ingredients aren’t fit for injectable use.

In a move tied to the administration's broader pricing push, the FDA 

released 55 new or revised product-specific guidances

 to support generic-drug development for more than 30 products that currently lack generic competition.

guidance on therapeutic equivalence evaluations and Orange Book TE codes

, closing out a draft that had been open since 2022.

Manufacturing Compliance: FDA-Issued Warning Letters

FDA enforcement activity was active throughout August. 

 was cited for distributing APIs without adequate process validation, incomplete batch records, and missing stability testing.

 drew scrutiny for continuing sterile manufacturing after repeated media-fill failures and inadequate visual inspection and has since initiated a voluntary recall.

 failed, according to the FDA, to test incoming components and did not investigate out-of-limit microbial results.

 faced findings on aseptic-processing design and environmental monitoring, with the FDA noting similar deficiencies across multiple company sites.

 was cited for incomplete laboratory records and a pattern of retesting until passing results were obtained without documented justification.

 was flagged for inadequate quality-unit oversight, improper product segregation, and gaps in distribution traceability.

Together, the letters underscore the FDA’s continued focus on aseptic technique, data integrity, and quality-unit authority as recurring inspection themes.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Deciphera's 

 for tenosynovial giant cell tumor, with Executive Director Julian Beach noting it “provides a new treatment option for patients with TGCT.”

, with Chief Safety Officer Alison Cave stating plainly that “there is no evidence that vaccines cause autism in children.”

staked out its regulatory position on microbiome-based medicinal products

, confirming they fall under existing UK medicines law—an area Beach called “one of the most interesting and fast-moving areas in medicine today.”

the first country in Europe to authorize Eli Lilly's oral orforglipron (Foundayo)

 for weight management and type 2 diabetes,

 with Beach noting MHRA was “pleased to be the first regulator in Europe to authorize this tablet,” though NHS availability awaits NICE evaluation.

 for chronic spontaneous urticaria via the International Recognition Procedure, based on trials in 925 adults.

Innovative Licensing and Access Pathway granted Innovation Passports

 to an investigational hepatocellular carcinoma therapy and a dementia-with-Lewy-bodies candidate, with MHRA's James Pound noting the program "helps developers engage with the regulatory system earlier and more effectively"; the next application window runs through November 4.

European Pharmacopoeia and EDQM standards

The European Directorate for the Quality of Medicines & HealthCare (EDQM), which publishes the 

, had a busy month of standards work. The directorate 

updated its guidance for electronic CEP submissions

, clarifying eCTD validation report formatting and how module 3 changes should be documented.

new general chapter on procoagulant activity testing

 for immunoglobulin preparations, describing 3 detection methods ahead of enforcement in July 2027.

reactivated its Botulinum Toxin Working Party

 to begin phasing the mouse LD50 assay out of botulinum toxin monographs, continuing the agency's 3Rs commitment.

 is open for public comment through September 30, introducing separate limits for ethylene glycol and diethylene glycol contamination across 12 macrogol grades.

collaborative study establishing replacement heparin sodium reference batches

 under its Biological Standardisation Programme,

revised guidance on using one CEP to describe a material in another CEP application

, aligning with CEP 2.0 and EMA quality-working-party principles.

What does Overton's FDA nomination mean for drug reviews? 

https://www.pharmtech.com/view/what-does-overtons-fda-nomination-mean-for-drug-reviews-

President Trump delivers largest prescription drug price drop in over 60 years. Press release. The White House. August 17, 2026. 

https://www.whitehouse.gov/releases/2026/08/president-trump-delivers-largest-prescription-drug-price-drop-in-over-60-years/

Novel drug approvals for 2026. FDA. Updated August 27, 2026. Accessed August 31, 2026. 

https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026

FDA approves new engineered viral immunotherapy for patients with treatment-resistant advanced melanoma. Press release. FDA. August 6, 2026. Accessed August 7, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma

FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma. August 6, 2026. FDA. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma

U.S. FDA approves Revolution Medicines’ RAS(ON) inhibitor daraxonrasib. Press release. Revolution Medicines. August 26, 2026. 

https://ir.revmed.com/news-releases/news-release-details/us-fda-approves-revolution-medicines-rasonquetm-daraxonrasib

FDA Grants Accelerated Approval to Iberdomide, Daratumumab and Hyaluronidase-fihj, and Dexamethasone. FDA. August 13, 2026. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone

FDA approves first drug to treat the full range of narcolepsy type 1 symptoms. US Food and Drug Administration. News Release. August 5, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms

Lantheus announces FDA approval of TAUKLARIFY™ (florquinitau F 18) injection. 

https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-tauklarifytm-florquinitau-f-18

Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA. Press release. Moderna. August 5, 2026. 

https://feeds.issuerdirect.com/news-release.html

FDA Approves Drug to Treat HIV Infection in Newborns. FDA. August 25, 2026. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-hiv-infection-newborns

FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults. Press release. FDA. August 27, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults

Ecopipam's D1 Receptor Approach Signals Pediatric Neuroscience Pathway. 

https://www.pharmtech.com/view/ecopipams-d1-receptor-approach-signals-pediatric-neuroscience-pathway

Determining Whether to Submit an ANDA or a 505(b)(2) Application. Draft guidance. FDA. August 2026. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determining-whether-submit-anda-or-505b2-application-0

Container Closure Systems for Human Drugs and Biological Products. Draft guidance. FDA. August 2026. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-human-drugs-and-biological-products

Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability. Federal Register. FDA. August 20, 2026. 

https://www.federalregister.gov/documents/2026/08/20/2026-16960/potency-assessment-of-active-immunotherapy-products-draft-guidance-for-industry-availability

FDA Reminds Compounders Not to Use Dietary Supplement-Grade Glutathione for Injectables. FDA. August 27, 2026. 

https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables

FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development. FDA. August 21, 2026. 

https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development

Evaluation of Therapeutic Equivalence. Final guidance. FDA. August 2026. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-therapeutic-equivalence

Warning Letter: Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. FDA. August 6, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tianjin-kilo-pharmaceutical-sci-tech-co-ltd-731761-08062026

Warning Letter: K.C. Pharmaceuticals, Inc. FDA. August 12, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kc-pharmaceuticals-inc-729870-08122026

Warning Letter: Suretec Innovations, LLC. FDA. August 13, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/suretec-innovations-llc-730122-08132026

Warning Letter: Eugia Pharma Specialities Limited. FDA. August 13, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026

Warning Letter: Auriga Research Pvt. Ltd. FDA. August 12, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026

Warning Letter: Safrel Pharmaceuticals LLC. FDA. August 7, 2026. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safrel-pharmaceuticals-llc-730520-08072026

Vimseltinib (Romvimza) Approved for Use in Adults to Treat Tenosynovial Giant Cell Tumours. MHRA. August 14, 2026. 

https://www.gov.uk/government/news/vimseltinib-romvimza-approved-for-use-in-adults-to-treat-tenosynovial-giant-cell-tumours

MHRA Reaffirms the Safety of Childhood Vaccination. MHRA. August 12, 2026. 

https://www.gov.uk/government/news/mhra-reaffirms-the-safety-of-childhood-vaccination

MHRA Sets Out Position on Regulation of Microbiome-Based Medicinal Products. MHRA. August 18, 2026. 

https://www.gov.uk/government/news/mhra-sets-out-position-on-regulation-of-microbiome-based-medicinal-products

UK First in Europe to Authorise Orforglipron for Weight Management and Type 2 Diabetes. MHRA. August 10, 2026. 

https://www.gov.uk/government/news/uk-first-in-europe-to-authorise-orforglipron-for-weight-management-and-type-2-diabetes

MHRA Approves Remibrutinib for Adults with Chronic Spontaneous Urticaria. MHRA. August 5, 2026. 

https://www.gov.uk/government/news/mhra-approves-remibrutinib-for-adults-with-chronic-spontaneous-urticaria

The Innovative Licensing and Access Pathway Grants Innovation Passports to Investigational Products for Cancer and Dementia. MHRA. August 4, 2026. 

https://www.gov.uk/government/news/the-innovative-licensing-and-access-pathway-grants-innovation-passports-to-investigational-products-for-cancer-and-dementia

Update to the Guidance for Electronic Submissions of CEP Applications. EDQM. August 19, 2026. 

https://www.edqm.eu/en/-/update-to-the-guidance-for-electronic-submissions-of-cep-applications

New General Chapter on Procoagulant Activity Testing of Immunoglobulin Preparations Soon to Be Published in the Ph. Eur. EDQM. August 10, 2026. 

https://www.edqm.eu/en/-/new-general-chapter-on-procoagulant-activity-testing-of-immunoglobulin-preparations-soon-to-be-published-in-the-ph.-eur

Phasing Out the Mouse LD50 Assay. EDQM. August 7, 2026. 

https://www.edqm.eu/en/-/phasing-out-the-mouse-ld50-assay

New Control of Ethylene Glycol and Diethylene Glycol in Macrogols 1444 Published for Comment. EDQM. August 4, 2026. 

https://www.edqm.eu/en/-/new-control-of-ethylene-glycol-and-diethylene-glycol-in-macrogols-1444-published-for-comment

Publication of a Collaborative Study on Ph. Eur. Heparin Sodium BRP Batches 5 and 6. EDQM. August 27, 2026. 

https://www.edqm.eu/en/-/publication-of-a-collaborative-study-on-ph.-eur.-heparin-sodium-brp-batches-5-and-6

Revised Guidance About the Use of a CEP to Describe a Material Used in an Application for Another CEP. EDQM. August 27, 2026. 

https://www.edqm.eu/en/-/revised-guidance-about-the-use-of-a-cep-to-describe-a-material-used-in-an-application-for-another-cep

Determining Whether to Submit an ANDA or a 505(b)(2) Application

Container Closure Systems for Human Drugs and Biological Products

https://www.federalregister.gov/documents/2026/08/14/2026-16638/container-closure-systems-for-human-drugs-and-biological-products-draft-guidance-for-industry

Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability

FDA reminds compounders not to use dietary supplement grade glutathione for injectables

FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development



https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-therapeutic-equivalence

Warning Letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.

Warning Letter to K.C. Pharmaceuticals, Inc.

Warning Letter to Suretec Innovations, LLC


Warning Letter to Eugia Pharma Specialities Limited

Warning Letter to Auriga Research Pvt. Ltd.


Warning Letter to Safrel Pharmaceuticals LLC


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safrel-pharmaceuticals-llc-730520-08072026

Ecopipam's D1 Receptor Approach Signals New Pediatric Neuroscience Pathway

What Does TAUKLARIFY's Approval Mean for Alzheimer's Drug Developers?

https://www.pharmtech.com/view/what-does-tauklarify-approval-mean-for-alzheimer-drug-developers

The FDA Gives Accelerated Approval to Melanoma Treatment

https://www.pharmtech.com/view/the-fda-gives-accelerated-approval-to-melanoma-treatment

Videos

In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.

PharmTech Weekly Roundup—August 28, 2026

, industry experts discussed a variety of topics that touched on the theme of control, including controlling manufacturing decisions, hold times, and nitrosamine risks. This week also saw a wave of pipeline and dealmaking news, from a 60% survival benefit in pancreatic cancer to a $2.25 billion consolidation play, that's reshaping how much formulation and manufacturing capacity the industry will need next.

In news this week, the FDA's approval of Revolution Medicines' treatment for metastatic pancreatic cancer 

cut the risk of death by 60% against chemotherapy

, validating RAS(ON) inhibition as a genotype-agnostic, all-oral approach set to influence oncology manufacturing.

GSK’s priority-review filing for Jemperli in previously untreated rectal cancer 

could let patients skip chemotherapy, radiation, and surgery entirely

, a shift that would also strain fill-finish capacity and cold-chain planning for an already-established biologic.

McKesson's $2.25 billion acquisition of Precision Medicine Group, which CEO Brian Tyler called 

a “meaningful step” in the company's oncology strategy

, signals that trial sponsors should expect more vertically integrated, single-vendor paths from data to commercial launch.

REGENXBIO's clinical hold on its Hunter syndrome gene therapy RGX-121, triggered by 

asymptomatic spine MRI findings investigators call likely benign

, shows how postmarket-style imaging surveillance is now entering into pre-approval gene therapy programs.

In the United Kingdom, a new Centrix Pharma Solutions–University of Sussex partnership aims to 

turn siloed formulation and process data into predictive, decision-ready analytics

, with Sussex's Kate Thorpe framing the goal as building data science capability that outlasts the project itself.

Experts explained a variety of topics this week on 

makes the case that hold-time limits in biopharmaceutical manufacturing aren't spelled out by regulators

. Manufacturers should set, justify, and defend their own standards.

Formulation scientist Gary Watts states that, as antibody-drug conjugates, bispecifics, and fusion proteins crowd the pipeline, 

stability must be engineered in from day one

, with machine-learning-driven preformulation screening increasingly deciding whether a molecule ever reaches a syringe.

Brian Drapeau warns that pharma’s real AI risk isn’t whether agentic systems produce correct answers, but 

whether organizations have actually mapped which decisions those agents are authorized to make

 before a quality unit ever sees the output.

Hovione’s Anthony Tantuccio makes the case that 

continuous direct compression can bypass granulation for select spray-dried dispersion formulations

, shifting tablet development from a default assumption to a deliberate, material-property-driven choice.

European Frontrunners’ columnist, Cheryl Barton, surveys a fast-maturing European bioprinting landscape, where firms are 

pushing 3D bioprinting toward implantable tissue and organ-on-a-chip drug screening

 faster than regulation can keep pace, even with the European Medicines Agency’s new additive manufacturing guidance.

This week’s PharmTech.com content covered AI agent authority, hold-time and nitrosamine risk frameworks, biologics formulation, 3D bioprinting, and major oncology and dealmaking news.

Susan Haigney

Articles