The Latest Breaking News from FDA

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…

Taking a dig at the U.S. formula shortages, a bizarre news article from North Korean state media randomly claimed that Kim Jong Un personally oversaw the perfection of the nation's baby formula recipe. 

Gainers AgriFORCE Growing Systems Ltd. (NASDAQ: AGRI) shares jumped 65.9% to close at $2.77 on Monday after gaining around 10% on Friday.

The baby formula shortage that has morphed into a crisis in the U.S. could soon see some relief following an agreement between market leader Abbott Laboratories (NYSE: ABT) and the Food and Drug Administration.

Abbott, one of the largest formula-makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported formula.