An independent Booz Allen Hamilton review found FDA has met its MDUFA V commitments to date. Authorized PCCPs rose to 88 in ...

Trevogrumab, a myostatin/GDF8-targeted antibody candidate, demonstrated ability to prevent lean-mass reduction in patients ...

Only North Dakota has finalized a rebate deal, while most states are waiting to evaluate manufacturer offers.

The redesign of the Medicare Part D program has paid off in dramatic fashion for biopharmaceutical companies, but the government commission advising Congress on Medicare issues wants course ...

CDER is increasing its focus on big data and analysis with a new office housing dedicated divisions for artificial ...

Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of ...

Adjustable Valve, a pediatric pulmonary heart valve designed to expand as a child grows. The novel device, the first ...

Rodan + Fields' President and CEO spoke with HBW Insight about the company’s push to build an omnichannel ecosystem and what ...

A biosimilar request for approval can arrive four to six months, and be reviewed, before the earliest lawful approval date, ...

ADARx, the 22nd drug developer to go public in the US in 2026, closed its first day up 13.8% from its IPO price. Also, Viking ...

Detailed Phase III data for JAK3/TEC inhibitor Litfulo (ritlecitinib) in nonsegmental vitiligo were presented at EADV. Pfizer ...

A key piece of Sandoz’s ‘Bio100’ strategy has fallen into place with the opening of a major biosimilars manufacturing plant ...