The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.
Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.
Following a priority review, Apellis Pharmaceuticals Inc. received U.S. FDA approval of a supplemental NDA making pegcetacoplan the second marketed treatment for complement 3 glomerulopathy and the first for primary immune complex membranoproliferative glomerulonephritis.
With the U.S. FDA’s approval of Vimkunya, Bavarian Nordic A/S is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older.
The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
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