Regulatory
The U.S. FDA’s Advisory Committee on Immunization Practices (ACIP) met yesterday to make a recommendation on the current pause of the Johnson & Johnson COVID-19 vaccine.
The approval marks the second approval for Trodelvy, which Gilead gained through its $21 billion acquisition of Immunomedics.
On Tuesday, Celularity received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its off-the-shelf natural killer cell therapy for malignant gliomas.
The U.S. Food and Drug Administration (FDA) granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes. This designation provides companies more support and the possibility of shorter development and review timelines.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 13, 2021.
The U.S. CDC and the U.S. FDA have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson.
The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.
The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.
The story of how the Ervebo came to be is not just an account of a broken contract, but also a cautionary tale.
The agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more previous system therapies, at least one for metastatic disease.
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