Omacor, (omega-3 acid ethyl esters) will be marketed in the United States by Reliant Pharmaceuticals, Liberty Corner, N.J., (908) 580-1200.
Gepotidacin NDA Under Priority Review by FDA for Uncomplicated UTI
Gepotidacin is a first-in-class oral antibiotic with a novel mechanism of action.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
FDA Approves Ceftobiprole Medocaril Sodium for 3 Indications
The FDA approved ceftobiprole medocaril sodium for injection (Zevtera) in April 2024.
FDA Roundup: Hemophilia B Therapy, Stelara Biosimilar Approval
Check out important updates from the FDA for the week of October 7.
FDA Approves First Weekly Subcutaneous Therapy for Hemophilia B
Marstacimab-hncq is the first non-factor and once-weekly treatment available for patients with hemophilia B and promises to reduce the burden of care.
FDA Approves Imuldosa, Biosimilar to Stelara
The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.