Topic

Articles

The FDA approved higher-dose semaglutide (7.2 mg) in 54 days under its new priority voucher program, signaling faster reviews for drug developers.

New Wegovy Dose Approved Under FDA’s CNPV

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

What FDA's NAM Guidance Means for Pharmaceutical Development

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

Creating Sustainable Operational Excellence in Pharma Manufacturing

The FDA will evaluate tildrakizumab-asmn for psoriatic arthritis. A 2026 decision is expected based on Phase III clinical trial data.

FDA Accepts Tildrakizumab-asmn sBLA for Active Psoriatic Arthritis

Videos

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities. 

PharmTech Weekly Roundup–March 13, 2026

Emily Null, MS, is a scientist with Steris Corp.

Mildred R. Bernardo is lead scientist with Steris Corp. 

Si Myra Tyson is a senior technical service associate for the Life Sciences Division of STERIS.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

This article reviews the use of Raman spectroscopy in a series of case studies to quickly identify the iron oxide compound(s), including magnetite and hematite, on the surface of representative endcaps or piping spool pieces. The article also provides a strategy using a detergent additive to remove magnetite without performing costly electro- or mechanical polishing.

Identification and Remediation of Type III or Class III (Magnetite) Rouge in Manufacturing Equipment and Water Systems

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

European Commission Approves Dosing Regimen for Fabry Disease Treatment

Developments across the sector highlight a period of rapid acceleration and structural modernization. 

PharmTech Weekly Roundup–March 6, 2026

Tony Cundell is principal consultant at Microbiological Consulting.

The author discusses analytical techniques associated with cleaning and disinfection; cleanroom operation; packaging component preparation; water-for-injection production; sterile product preparation; and aseptic filling, stoppering, and sealing.

How Are Analytical Techniques Used in Aseptic Processing?

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

Quality Systems