A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous communication helps organizations identify and proactively address any ...

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 US Food and Drug Administration (FDA) has approved Iterum Therapeutics' new drug application (NDA) for ORLYNVAH (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract ...

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 ...

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 ...

ORLYNVAH is indicated for the treatment of uUTIs in adult women. Credit: 9nong/Shutterstock. The US Food and Drug Administration (FDA) has approved Iterum Therapeutics‘ new drug application (NDA) for ...

The FDA has granted approval to revumenib for the treatment of adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia. 1 Data from the phase 1/2 AUGMENT-101 trial, as ...

Gilead Sciences withdrew Trodelvy's FDA accelerated approval for urothelial cancer after the TROPiCS-04 study failed to meet the primary endpoint of overall survival. The TROPiCS-04 study showed ...

Less than a year after obtaining an FDA approval for its first foray into pulsed field ablation, Medtronic has done it again. The agency handed down a green light to the medtech giant’s all-in ...

Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to ...

Iterum Therapeutics (ITRM) plc announced that the U.S. Food and Drug Administration has approved Iterum’s new drug application for Orlynvah for the treatment of uncomplicated urinary tract ...

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at ...