FDA accepts Capricor's Biologics License Application for priority review, advancing deramiocel for DMD cardiomyopathy.

On March 19, the Food and Drug Administration granted traditional approval to pembrolizumab, or Keytruda, marketed by Merck (MRK), with ...

Alexion Pharmaceuticals’ ravulizumab for the prevention of delayed graft function after renal transplantation was granted FDA orphan ...

The Food and Drug Administration unexpectedly canceled an annual meeting of its advisers to update next season's influenza vaccines, an adviser on the panel and multiple officials tell CBS News ...

The registry will be mandatory for everyone 14 and older who doesn’t have legal status, according to a Tuesday statement from U.S. Citizenship and Immigration Services, a branch of the Department of ...

Celltrion’s Remsima surpassed 1 trillion won ($699 million) in sales last year, making it the first drug developed by a Korean company to achieve blockbuster status, the biotech company said ...

Blockbuster drugs are medications that generate $1 billion+ in annual sales. Drug patents typically last 20 years, but market exclusivity is often shorter. Post-patent, revenue can drop by 80% as ...

Mutations in GRIN genes lead to GRIN-related neurodevelopmental disorders. Credit: Jo Panuwat D/Shutterstock. The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ...

Multnomah County’s multimillion dollar program designed to keep people caught with hard drugs out of jail and direct them into addiction treatment or shelter has achieved a roughly 16% success ...

To make it safer, the government has made it compulsory for every vehicle to have a tamper-proof High-Security Registration Plate (HSRP). The Maharashtra government has already extended the deadline ...

Makers of copycat versions of Novo Nordisk's (NVO) popular weight-loss drug semaglutide, also known as Ozempic and Wegovy, are suing the FDA for removing the GLP-1 medication from its shortage list.