The Latest Breaking News from FDA

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.

FDA leadership didn’t ‘receive direct copies of the complaint due to an isolated failure in FDA’s mail room, likely due to COVID-19 staffing issues’

Verrica Pharmaceuticals Inc (NASDAQ:VRCA) was slapped with a third FDA rejection for YCANTH (VP-102) as general contract manufacturing organization challenges continue to plague the approval. RBC Capital Markets has downgraded the stock to Sector Perform from Outperform and lowered the price target from $16 to $4. The analysts note that the issues fall outside of…

The Food and Drug Administration (FDA) has accepted for review Phathom Pharmaceuticals’ (NASDAQ: PHAT) New Drug Application (NDA) of its lead drug candidate Vonoprazan for the healing of all grades of erosive esophagitis (EE).

The Fed’s aggressive interest rate increases to tame multi-decade high inflation, and an anticipated economic slowdown, have exacerbated market volatility of late. To protect against the market uncertainties, we think investors should consider investing in low-beta stocks Merck (MRK), Gilead Sciences (GILD), and AmerisourceBergen (ABC). Let’s discuss why.

The FDA is easing regulations to allow infant formula imports from Britain, bringing around 2 million cans onto empty shelves by June to ease a nationwide shortage, Reuters reported. The FDA said it was "exercising enforcement discretion" to allow Britain-based Kendal Nutricare to import certain infant formula products under the Kendamil…