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 ...

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 ...

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 ...

EBITDA(1) of € 496.3 million, +9.6%, margin on revenue of 37.5% Adjusted net income(2) of € 327.8 million, +8.9% Net income of € 216.1 million, -4.1% Free cash flow(4) of € 256.8 million, +€ 0.2 ...

CHMP has advised that Alhemo be approved for people with severe hemophilia A and moderate or severe hemophilia B without inhibitors.

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases ...

Munich news, health insurance, technology, jobs and other topics for expatriates. The Eye Newspapers covers daily news and offers services for foreigners.