The FDA has approved Benlysta for SC administration using an autoinjector in patients 5 years of age and older with active LN.

During a live event, Alfred L. Garfall, MD, discussed talquetamab dosing strategies and efficacy after dose reduction in ...

The FDA has approved Benlysta for SC administration using an autoinjector in patients 5 years of age and older with active LN.

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead ...

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a ...

TG Therapeutics sees growth from BRIUMVI’s MS launch, but competition, pipeline risks, and valuation concerns limit upside.

The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing an alternative treatment as opposed to traditional surgical procedures.

Moderna's RSV vaccine gets expanded approval for 18-59 year olds at high risk of severe illness, marking a significant step in vaccine protection.

A recall of mislabeled cases of Dr. Pepper Zero Sugar has been upgraded amid a serious health risk, according to the US Food and Drug Administration.

Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after the Food and Drug Administration placed a clinical hold, the drug ...

A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug Administration's (FDA) second-highest risk level. Carley's Inc. voluntarily ...