The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...

The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in ...

FDA extended the aficamten decision deadline to Dec. 26 after classifying the REMS submission as a major amendment to the NDA ...

File this under “So close, yet so far.” After several years of struggling with regulatory hurdles to win approval for its rare disease drug, Stealth BioTherapeutics had expected the U.S. Food ...

Urcosimod has received FDA fast track designation for neuropathic corneal pain, enabling expedited regulatory processes and ...

Compounded drugs are custom-made ... receptor agonist. A key difference between compounded semaglutide and Ozempic is the lack of FDA approval for compounded semaglutide. Some compounded ...

Tirzepatide is now approved for the treatment of obstructive sleep apnea, highlighting the drug class' potential in sleep medicine.

The US Food and Drug Administration has approved nipocalimab-aahu, a new FcRn- blocking monoclonal antibody, for the ...

Sanofi and Regeneron Pharmaceuticals drug Dupixent has won ... addressable U.S. market covered by the FDA approval is 300,000. Antihistamines target H1 receptors, receptors on immune cells that ...

The company plans to file for FDA approval of its drug, called cytisinicline ... cytisinicline partially blocks the nicotine receptors in the brain so smoking is less pleasurable and therefore ...