Cogent Biosciences recently completed and submitted its New Drug Application to the FDA for bezuclastinib in previously treated GIST patients, supported by Phase 3 PEAK data showing materially longer ...

With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an ...

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational ...

Teva Pharmaceutical Industries Ltd. TEVA announced that the FDA has approved its biosimilar to Amgen’s AMGN blockbuster drug, ...

Merck (NYSE:MRK) received expanded EU approval for KEYTRUDA-based regimens in platinum-resistant ovarian cancer, making it ...

MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...

Shares of Scholar Rock SRRK rose 14% on Tuesday after the company announced the resubmission of a regulatory filing to the ...

Mitapivat has been approved in the US under the Pyrukynd trade name since 2022 as a treatment for haemolytic anaemia in ...

The company is seeking clearance in additional gynecological indications to support outpatient use of its surgical robot.

Optiscan Imaging has taken a significant step toward entering the lucrative US veterinary market, submitting a regulatory ...