Analysts say the departure of the CBER head may alleviate overhang in the cell and gene therapy space. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and ...

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion ...

Aurobindo Pharma to acquire US-based Lannett for $250M, gaining a strategic local manufacturing base to offset tariffs and ...

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...

Vinay Prasad, a top FDA official, suddenly departed after a series of controversial decisions about a Duchenne gene therapy ...

AbbVie, Bristol Myers Squibb and Eli Lilly appear “relatively well-positioned,” while Novartis and Roche look more at risk, ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...

The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

The FDA has approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH) for the treatment of adults with GHD.