Drugs

CDER/CBER Add 84 Employees in Fourth Quarter

FDA's drug and biologics review centers added a net 84 employees during the fourth quarter of fiscal year 2026, reversing earlier staffing losses but leaving their combined workforce about 18% below its level at the beginning of fiscal 2025, according to newly updated agency hiring data.

The figures show that the CDER gained 137 employees and lost 71 during the quarter ending 9/30, leading to a net gain of 66. CBER gained 43 employees and lost 25, for a net increase of 18. For the full fiscal year, CDER recorded a net gain of 10 employees, while CBER lost 36, producing a combined net reduction of 26.

The results follow much larger reductions in fiscal 2025, when CDER lost a net 1,093 employees and CBER lost 224. Combined staffing at the two centers declined from 7,417 at the beginning of fiscal 2025 to 6,074 at the end of fiscal 2026, a reduction of 1,343 employees, or 18.1%.

Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

Merck's investigational GLP-1/glucagon receptor dual agonist efinopegdutide (MK-6024) demonstrated higher rates of MASH resolution and liver fibrosis improvement than placebo in a Phase 2b trial involving patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis. The results, presented at the American Association

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

FDA officials say drug manufacturers may be able to establish dosing recommendations and characterize drug-drug interaction risks without conducting additional clinical studies, including through pharmacokinetic modeling and real-world data, provided the evidence is scientifically justified. During a series of FDA presentations released 11/4 on [Drug Interaction Information

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

FDA has granted Janssen Biotech accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) and its use in treating adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. “HNSCC is an aggressive, life-threatening disease

Significantly More Unannounced Foreign Inspections

FDA associate commissioner for inspections and investigations Elizabeth Miller says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus newsletter, she spoke at the Association for Accessible Medicines’ GRx+

Read more

Merck's Efinopegdutide Shows MASH Resolution, Fibrosis Improvement

FDA Clarifies Drug Interaction Study Requirements, Labeling Expectations

Rybrevant Faspro OK’d in Aggressive Head and Neck Cancer

Significantly More Unannounced Foreign Inspections