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 ...

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.

EMA committee recommends approval of BeOne Medicines’ Tevimbra to treat neoadjuvant/adjuvant NSCLC: San Carlos, California Wednesday, July 30, 2025, 12:00 Hrs [IST] BeOne Medici ...

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.

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

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

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.

The opioid-like substance is sold in gummies, tablets and drinkable shots, mainly in gas stations and convenience stores.

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