Vera Therapeutics received priority review from the FDA for its biologics license application for atacicept to treat adults with immunoglobulin A nephropathy. The application was submitted under the ...

There's now a prescription GLP-1 pill for weight loss on the market. Here are six key things to know about it.

The Food and Drug Administration has approved Nereus (tradipitant) for the prevention of vomiting induced by motion in adults.

CK0804, a novel Treg therapy, gains FDA orphan drug status for myelofibrosis, promising new hope for patients with limited treatment options. CK0804, an investigational allogeneic regulatory T cell ...

The FDA has approved Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

Until a few years ago, the butterfly pea flower was just another climbing plant in my village,” said Nilam Brahma who lives in Anthaigwlao, a village in the northeastern Indian state of ...

Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

Struggling with alcohol cravings? Naltrexone targets the brain's reward center to minimize drinking urges and reduce harmful ...

"Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis" was originally created and published by ...

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical ...