The U.S. Food and Drug Administration agreed to place Regeneron Pharmaceuticals Inc.’s Biologics License Application (BLA) for the Covid-19 drug REGEN-COV under priority review with a target action date of April 13, 2022.
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
As the fraud trial of Theranos founder Elizabeth Holmes headlines the pharma legal news, other court-related cases are taking place, including a ruling in the legal spat between Takeda and AbbVie over a supply agreement for the prostate cancer drug Lupron.
The U.S. Food and Drug Administration on Sept. 20 approved South Korean drugmaker Samsung Bioepis Co. Ltd. and Biogen Inc.’s biosimilar rival to Roche Holding AG’s blockbuster eye medicine Lucentis.
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.
The U.S. Food and Drug Administration granted the Pfizer-BioNTech Covid-19 vaccine Comirnaty full approval.
The U.S. Food and Drug Administration rejected Sesen Bio’s lead candidate Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer.
Humira could generate more than $20 billion in sales for AbbVie during 2021 while Merck’s Keytruda is on track to become only the second prescription medicine ever to exceed $16 billion in annual sales.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Henderson, Nev.-based Spectrum Pharmaceuticals.
North Carolina’s life sciences ecosystem continues to expand as Amgen announced plans to build a new $550 million biologics manufacturing center in Holly Springs in the Research Triangle Park area.
