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 ...

Harmony Biosciences Holdings said the Food and Drug Administration has turned away its application seeking expanded approval of its Wakix narcolepsy drug for the treatment of excessive daytime ...

On-demand video webcast now available here ISELIN, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in ...

Q4 2024 Earnings Call Transcript February 18, 2025 Halozyme Therapeutics, Inc. beats earnings expectations. Reported EPS is ...

Q4 2024 Earnings Call Transcript February 13, 2025 Operator: Good morning, and welcome to Agios’ Fourth Quarter 2024 ...

Pfizer's strong Q4 2024 results showcase growth in cancer drugs and Vyndaqel sales. Learn why PFE stock is a top pick for ...

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly ...

Annie Cooper couldn't free her 5-year-old son, Thomas, from a hyperbaric chamber as flames engulfed him last month. Her ...

Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...

We assign Siegfried a Medium Morningstar Uncertainty Rating. Its business is relatively stable, with high switching costs and good visibility due to long-term customer contracts. However, small ...

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval ...