The Latest Breaking News from FDA

Many other companies use the peanut butter — the cause of a salmonella outbreak — and now they have recalls of their own. The FDA says the products made it to at least 10 other countries.

 

FDA officials appeared before a congressional panel to answer questions about the crisis after Abbott Laboratories (NYSE: ABT) recalled some baby formula products and closed its manufacturing plant in Sturgis, Michigan. 

U.S. stocks traded higher this morning, with the Nasdaq Composite gaining around 200 points on Thursday.

Reata Pharmaceuticals (NASDAQ: RETA) announced that the U.S. Food and Drug Administration has accepted New Drug Application (NDA) for its lead drug candidate omaveloxolone for the treatment of patients with Friedreich's ataxia.

The U.S. Food and Drug Administration has granted Fast Track designation to Pfizer’s (NYSE: PFE)  Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).

Here's a roundup of top developments in the biotech space over the last 24 hours:

Aflatoxin, a chemical produced by infectious mold, could be coming to the Corn Belt thanks to climate change

COVID-19 case numbers are rising again in the U.S. – including among children. In mid-May 2022, the Food and Drug Administration authorized a booster shot of the COVID-19 vaccine for U.S. children ages 5 to 11, and the Centers for Disease Control and Prevention followed by recommending a booster shot…

Based on the review of approximately 460 patients, Data Safety and Monitoring Board (DSMB) determined that the evaluation of NRx Pharmaceuticals Inc's (NASDAQ:NRXP) Zyesami (aviptadil) should cease due to futility. Aviptadil was the sole remaining investigational medicine in ACTIV-3b targeted at critical-ill COVID-19 patients. ACTIV-3b study evaluated Zyesami and Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir)…

WASHINGTON — Sluggish response and questionable decisions by the Food and Drug Administration exacerbated the nation's infant formula shortage, agency officials told lawmakers at a congressional hearing on Wednesday.