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

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

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 ...

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

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 ...

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

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The FDA had asked Sarepta to voluntarily halt all shipments of Elevidys following the deaths of three nonambulatory Duchenne ...

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 ...