USFDA

The Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

GSK plc announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025.

Strides Pharma Science Limited (Strides) today announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Fluoxetine Tabs 10 mg and 20 mg, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac® Tablets of Eli Lilly.

Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that the US Food and Drug Administration (FDA) approved ZEVTERA® (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 mo