The FDA has approved a self-administered autoinjector form of anifrolumab for the treatment of systemic lupus erythematosus, ...

The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...

After years of off-label use, veterinarians now have the first FDA-approved amlodipine formulation specifically indicated for ...

The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up ...

The FDA approved Breztri Aerosphere, a single-inhaler triple therapy, as a maintenance treatment for patients aged at least ...

By Ahmed Aboulenein WASHINGTON, April 28 (Reuters) - The U.S. Food and Drug Administration launched a pilot program on Monday ...

Ultreon 3.0 uses AI and OCT to provide real-time, high-resolution imaging during minimally invasive heart procedures.

Tandem Diabetes Care has received approval from the US Food and Drug Administration (FDA) for its Control-IQ+ automated ...

The FDA has granted accelerated approval to Otarmeni™ (lunsotogene parvec-cwha), the first gene therapy for pediatric and adult patients with OTOF-related sensorineural hearing loss.

In a historic leap for medical science, the U.S. Food and Drug Administration (FDA) has greenlit the first-ever gene therapy ...

Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns ...

PSG’s research found that payers are placing more attention on specialty drugs covered under the medical benefit, showing ...