Treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis are under review.

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved ...

The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...

Eight years after it was established partly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only ...

KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral treatment for a type of hereditary swelling disorder, sending its shares ...

A new twice-yearly shot could be a "game changer" in the fight against AIDS, but experts' hopes have dimmed because of the ...

Celltrion USA launches 2 denosumab biosimilars, Stoboclo and Osenvelt, enhancing treatment options for osteoporosis and ...

Zegfrovy (sunvozertinib) received accelerated FDA approval for NSCLC patients with EGFR exon 20 insertion mutations post-platinum-based chemotherapy progression. The Oncomine Dx Express Test was ...

The Filchak family is advocating for FDA approval of elamipretide, an experimental drug.

Opinion How we plan to cut FDA drug approval time by months Qualifying manufacturers will be able to submit some data while clinical trials are ongoing.

The FDA has approved Zegfrovy (sunvozertinib) for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.