The FDA recently granted EXG-34217 Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) Designation.

As of February 17, 2025, 1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval- ...

Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...

The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog, to improve glycemic control in patients with diabetes mellitus.

The cuts hit the FDA’s medical device center particularly hard, impacting product reviewers and researchers of AI-enabled ...

The quick answer is, it's complicated. Number one, quality. Number three, delay of the product. because it's no longer ...

Harmony Biosciences is facing more of a nightmare than sweet dreams on the road to securing a new use for its excessive ...

The U.S. Food and Drug Administration (FDA) has accepted for filing PTC Therapeutics’ New Drug Application (NDA) for ...

Anifrolumab (brand name Saphnelo) reduced the risk of long-term organ damage progression by about 60% in patients with ...

Some doctors say drugs that improve muscle mass could benefit older or infirm people at greater risk of falls and fractures.

Vincent Gaynor remembers, almost to the minute, when he realized his part in birthing the breakthrough gene therapy Zolgensma ...

Shares of Moderna, along with other vaccine makers, dropped further this year as lawmakers advanced U.S. President Donald ...