Food and Drug Administration (FDA)
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It’s a relatively slow month ahead for July in terms of PDUFA dates for the U.S. FDA. However, there are several dates pending throughout the month. Here’s a look at three for the next two weeks.
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
The FDA guidelines also indicated a vaccine would not be approved unless it had “clearly demonstrated” proof of the vaccine’s safety and effectiveness in a clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The U.S. Food and Drug Administration (FDA) issued Heron Therapeutics a Complete Response Letter (CRL) for its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
DBV Technologies, located just outside Paris, announced it is cutting jobs while it awaits news from the U.S. Food and Drug Administration (FDA) about its application for Viaskin Peanut.
The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.
Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.
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