After months of uncertainty and controversy, the FDA has given approval to Sarepta's Duchenne muscular dystrophy drug – even though it hasn't yet shown any proof it can slow progress of the ...

Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a second – Amvuttra – which has a simpler ...

The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...

Parkinson’s disease is a chronic neurological disorder marked by symptoms such as tremors and muscle rigidity. Credit: chainarong06/Shutterstock. The US Food and ...

Credit: BlurryMe/Shutterstock. The US Food and Drug Administration (FDA) has approved a new presentation of Alvotech and Teva Pharmaceuticals’ SELARSDI (ustekinumab-aekn), expanding its label to ...

The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up ...

The Affera mapping and ablation system with the Sphere-9 catheter [Images courtesy of Medtronic] Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system ...

Obe-cel is the first FDA-approved CAR T-cell therapy for B-ALL without a REMS requirement, based on the FELIX trial's positive outcomes. The FELIX trial reported a 63% complete remission rate ...

Vyloy has become the first and only CLDN18.2-targeted therapy approved in the United States. The approval is based on the phase 3 SPOTLIGHT and GLOW clinical trials, in which approximately 38% of ...

Oct 18 (Reuters) - The U.S. Food and Drug Administration approved Astellas' (4503.T), opens new tab therapy to treat a type of gastric cancer, the health regulator's website showed on Friday.