The Latest Breaking News from FDA

Americans generally don’t spend much time thinking about the nation’s blood supply.

They bounce, they squeak, they whistle, they fling sauce in unpredictable directions — and I love it

Since their debut just 18 months ago, three COVID-19 vaccines have saved an estimated 2.2 million American lives, changed the trajectory of a pandemic and inspired all manner of conspiracy theories.

The FDA has decided not to authorize fluvoxamine, an antidepressant, to treat COVID-19. The agency that data has not shown the drug to be an effective therapeutic for fighting the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine…

The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ:SRNE) investigational new drug application (IND) for Abivertinib (Fujovee) for Phase 2 MAVERICK study in metastatic castrate-resistant prostate cancer (mCRPC).  The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-naïve and abiraterone-progressing…

With children hospitalised and parents paying up to $100 for a can, the president has now invoked a wartime measure to try to ensure there is enough formula to feed America’s babies

The money is intended to help the FDA prepare for potential future shortages.

The Food and Drug Administration expanded authorization of Pfizer-BioNTech's COVID vaccine to enable kids ages 5 to 11 who were vaccinated at least five months ago to get a third shot.

The FDA has authorized the first nonprescription test to detect Covid-19, influenza, and respiratory syncytial virus (RSV). The test, called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, was developed by Laboratory Corp of America Holdings (NYSE:LH). It can be sold directly to consumers online or at retail.  A person can self-collect a nasal…

The FDA is expected to authorize a booster shot of Pfizer Inc (NYSE:PFE) / BioNTech SE's (NASDAQ:BNTX) COVID-19 vaccine for children aged 5 to 11 probably by today, the New York Times reported, citing people familiar with the matter. The companies submitted an application to the FDA for authorization last month. They have cited data from…

Applied Genetic Technologies Corp (NASDAQ:AGTC) reported three-month interim data from its ongoing Phase 2 Skyline trial of AGTC-501 for X-linked retinitis pigmentosa (XLRP), an inherited condition causing progressive vision loss in boys and young men.  AGTC-501 is a recombinant AAV viral vector-based gene therapy targeting mutations in the RPGR gene. There were robust…