Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA). The new tablet is ...

The U.S. Food and Drug Administration’s (FDA) chief counsel resigned two days after her appointment, according to a Thursday announcement from the agency. “Hilary K. Perkins has ...

The company previously received and responded to an FDA Form 483 tied to the inspection, but the U.S. drug regulator apparently found its response lacking. Tyche's warning letter focuses primarily ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.

A study shows that high-grade glioma tumor cells harboring DNA alterations in the gene PDGFRA responded to the drug avapritinib, which is already approved by the United States Food and Drug ...

NDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGSIf approved, FILSPARI could become the first and ...

This would increase transparency for consumers as well as the FDA's oversight of food ingredients considered to be safe, Kennedy said. Sign up here. "For far too long, ingredient manufacturers and ...

The FDA’s Vaccines and Related Biological Products Advisory Committee had been scheduled to meet Thursday to weigh in on the composition of the flu shots, but that session was canceled without ...

Dr. Marty Makary — a surgeon, author and researcher — lauded the FDA’s “gold-standard science” in testimony before the Senate’s health committee, which must vote on whether to advance ...

The Senate Committee on Health, Labor and Pensions voted Thursday to approve Marty Makary as commissioner of the Food and Drug Administration. He will likely be confirmed in the full Senate.

Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...