Several rare disease patient populations received their first-ever FDA-approved drug since Rare Disease Day last year, ...

ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.

Dog owners can anticipate a new anti-aging pill that has achieved a key FDA milestone for efficacy, with expected market ...

The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on ...

As we observe Rare Disease Day today, let us take a look at seven drugs poised to be approved to address rare diseases in ...

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

Eli Lilly is now offering four doses of Zepbound in self-administration vials. The lower-cost self-pay option targets people ...

The Biden administration, in what it called an “AI talent surge,” ushered in a wave of AI experts to various roles across the ...

John Curley is joined by Dr. Brennan McKenzie, a veterinarian for San Francisco based start-up "Loyal". This week, Loyal received critical FDA approval for fu ...

Q4 2024 Earnings Call Transcript February 28, 2025 Amneal Pharmaceuticals, Inc. misses on earnings expectations. Reported EPS ...