GSK has garnered FDA approval for its pentavalent meningococcal ... Penmenvy is a combination of GSK's already-approved vaccines Bexsero and Menveo, which together brought in more than £1.4 ...

The FDA has started a review of GSK’s five ... The new vaccine is a combination of GSK’s already-approved vaccines Bexsero and Menveo and is designed to protect against meningitis and blood ...

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

Perspective from Andrew A. Moshfeghi, MD, MBA The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis affecting the posterior ...

Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.

NDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGSIf approved, FILSPARI could become the first and ...

A study shows that high-grade glioma tumor cells harboring DNA alterations in the gene PDGFRA responded to the drug avapritinib, which is already approved by the United States Food and Drug ...

Biotech company Neurotech Pharmaceuticals this month received regulatory approval for its treatment of a a neurodegenerative ...

Joseph Borzelleca published a study on the food coloring Red No. 3. The FDA cited his work when banning the additive in ...

Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...

The Senate Committee on Health, Labor and Pensions voted Thursday to approve Marty Makary as commissioner of the Food and Drug Administration. He will likely be confirmed in the full Senate.