Regulatory Oversight and Compliance

FDA Posts Slate of Seven Warning Letters Following Company Inspections

June 12, 2025

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

FDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE

June 02, 2025

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

Geopolitical Shifts Change Nature of Pharma Partnerships

May 28, 2025

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

April 30, 2025

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

April 28, 2025

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

FDA Announces New Policy on Advisory Committee Members

April 18, 2025

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

Bavarian Nordic Chikungunya Vaccine Recommended by CDC's ACIP

April 18, 2025

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Bayer Announces FDA’s First Full Approval of NTRK Inhibitor

April 14, 2025

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

BDD Opens GMP Manufacturing Facility in Scotland

April 11, 2025

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

Tariff Pause Reinforces Uncertainty Among Biopharma Professionals

April 10, 2025

Even with, or perhaps because of, the rapidity with which changes in United States policy are developing, many in the bio/pharmaceutical industry are taking a longer view.