Page 50 - Human Use News Today

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial ...

European Commission Approval Decision Expected Q4 2023 Opinion Based on Positive Results from Global Phase 2 and Ongoing Extension Study  U.S. Food and Drug Administration PDUFA Target Action Date...

By Colin Kellaher Merck & Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval...

These are the stocks posting the largest moves in midday trading.

Shares of PTC Therapeutics, Inc. (PTCT) are declining more than 34 percent on Friday morning trade after the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has given a negative opinion to its conditional authorization and full marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Friday morning, the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of PTC Therapeutics Inc's (NASDAQ: PTCT) Translarna (ataluren) for nonsense m

Nearly 10 years since the approval of naltrexone/bupropion, there’s been no CV outcomes study, leaving safety in question.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.

These are the stocks posting the largest moves in midday trading.