Government & Policy

U.S. Food And Drug Administration (FDA)

Drug and device approvals, safety communications, recalls, and regulatory actions from the FDA.

U.S. Food And Drug Administration (FDA)Source 3 days ago

FDA grants accelerated approval to Rybrevant Faspro for head and neck cancer

What happened The FDA granted accelerated approval on November 5 to Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and immunotherapy.

Confirmed · 1 source

Evidence

U.S. Food And Drug Administration (FDA)Source 6 days ago

FDA issues final guidance on potency assurance for cell and gene therapies

What happened The FDA issued final guidance on November 2 recommending a science- and risk-based potency assurance strategy for cellular and gene therapy products.

Confirmed · 1 source

Evidence

U.S. Food And Drug Administration (FDA)Source 8 days ago

FDA grants accelerated approval to Voceryq for recurrent respiratory papillomatosis

What happened The FDA granted accelerated approval on October 30 to Voceryq for adults with recurrent respiratory papillomatosis, the first U.S. approval of a plasmid DNA-based immunotherapy.

Confirmed · 1 source

Evidence

U.S. Food And Drug Administration (FDA)Source 9 days ago

Vitality Works recalls Whole Foods ashwagandha capsules over Salmonella risk

What happened Vitality Works recalled one lot of 365 Whole Foods Market ashwagandha capsules because of potential Salmonella contamination, according to its announcement posted by the FDA.

Confirmed · 1 source

Evidence

U.S. Food And Drug Administration (FDA)Source 9 days ago

FDA authorizes marketing of 24 Velo nicotine pouch products

What happened The FDA authorized marketing of 24 Velo nicotine pouch products made by Modoral Brands Inc. on October 30 through its premarket tobacco product application pathway.

Confirmed · 1 source

Evidence