The approval is supported by strong preclinical data demonstrating MP1032's capacity to sustain muscle function.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.

The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new ...

The US Food and Drug Administration (FDA) has lifted a pause in the use of Valneva’s chikungunya vaccine Ixchiq in older ...

QNRX READ THE FULL QNRX RESEARCH REPORT FDA clears initiation of 2nd NS pivotal whole body clinical study for QRX003, CL-QRX003-002 Quoin Pharmaceuticals (NASDAQ:QNRX) reported 2Q25 results today and ...

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response ...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults ...

(RTTNews) - AB Science (ABSCF.PK) announced FDA and EMA authorization of a confirmatory Phase 3 trial of masitinib in metastatic castrate-resistant prostate cancer, using a harmonized protocol and ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an 8-year-old boy who had received Elevidys, Sarepta Therapeutics Inc.’s ...

2. CSL's garadacimab, a first-in-class factor XIIa inhibitor, receives FDA and EMA filing acceptance. CSL. News release. December 14, 2023.

Drug regulators in the European Union (EU) are sticking to their recommendation to suspend the sale of dozens of generic drugs because of flawed clinical trials conducted in Hyderabad, India ...

Contacts Media Relations: +1 (212) 733-1226 [email protected] Investor Relations: +1 (212) 733-4848 [email protected] Industry: Biotechnology FDA Health Pharmaceutical Clinical Trials ...