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

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

Eli Lilly's appeal of a decision by the EMA's human medicines committee not to approve its Alzheimer's disease therapy ...

The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.

The drug failed to meet its primary endpoints in clinical trials, but subgroup analyses hinted at modest benefits.

PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 ...

A key advantage of the drug is its oral route of administration, offering patients a more convenient alternative to ...

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

(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 ...

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 ...