One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
The U.S. Food and Drug Administration extended the Prescription Drug User Fee Act date for Merck’s supplemental Biologics License Application (sBLA) for Vaxneuvance, a pneumococcal conjugate vaccine intended for preventative use in infants and children.
Taiho Oncology Inc. and Taiho Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions.
Incyte Corporation reported that the U.S. Food and Drug Administration pushed back the review of the company’s supplemental New Drug Application for Opzelura (ruxolitinib cream) for vitiligo.
Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.
Each new president enters the White House with big dreams and unique challenges. For President Joe Biden, 2021 was dominated by the evolving COVID-19 pandemic, an historically difficult transition of power, and a focus on packing an ambitious combination of economic relief, infrastructure investment, and social spending initiatives into a handful of multi-trillion dollar omnibus bills to push through a tightly-divided Congress.
The U.S. Food and Drug Administration extended Legend Biotech Corporation’s Prescription Drug User Fee Act (PDUFA) target date for the drug cilta-cel that the company is developing with partner Janssen Biotech to treat relapsed and/or refractory multiple myeloma.
The U.S. Food and Drug Administration accepted for filing the New Drug Application submitted by Acer Therapeutics Inc. and the company’s collaboration partner Relief Therapeutics Holding SA for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders.
Shares of Verrica Pharmaceuticals plunged after the company received a Complete Response Letter from the U.S. Food and Drug Administration for an experimental treatment for molluscum contagiosum (molluscum).
The U.S. Food and Drug Administration accepted for review a Biologics License Application (BLA) for the anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy.
