German drugmaker Bayer on Friday won an endorsement by the European Medicines Agency to extend the intervals between shots of ...

NEW YORK (Reuters) -Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently ...

Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK inhibitor. The drug is now fully approved in the United States for ...

The U.S. Food And Drug Administration (FDA) granted full approval to Bayer AG’s (OTC:BAYRY) Vitrakvi (larotrectinib) for adult and pediatric patients with solid tumors that have a neurotrophic ...

70. WASHINGTON — The workers who review drugs and devices and inspect manufacturing plants were protected when the Trump administration fired thousands of Food and Drug Administration employees.

Bayer AG BAYRY recently announced that ... or preserved LVEF (HFpEF). With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the third quarter ...

Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure. Bayer on ...

8 The FDA’s decision to grant Priority Review designation to our application underlines the significant unmet need these patients face." ...

FDA sets an August 31, 2025, action date for Capricor’s deramiocel BLA review. Capricor may receive a Priority Review Voucher if approval comes by September 2026. Get 5 ‘Hidden Gem’ stock ...

At least 11 employees working at the FDA's Center for Devices and Radiological Health - which oversees medical device reviews - have received calls since Friday saying they could return to work on ...

Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...