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

The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.

IntraBio Inc., a biopharmaceutical company focused on developing therapies for rare neurological diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Commi ...

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

MRNA's second-quarter results are likely to spotlight a sharp decline in Spikevax sales, RSV uptake and key pipeline ...

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

EMA encourages NAMs to replace animal testing, aligning with 3Rs principles, and has published a concept paper on regulatory ...

Kinvard Bio Inc., a biotechnology company pioneering a next-generation class of broad-spectrum antibiotics, today announced it has bee ...

Tsingke Biotech, a leading provider of synthetic biology and nucleic acid solutions, successfully hosted the 2025 Small Nucleic Acid Therapeutics Roundtable on July 26 in Beijing. The event convened ...

Under terms of the deal, Bavarian Nordic shareholders will receive an all-cash offer at a premium, with plans to delist the ...