The Latest Breaking News from FDA

U.S. stocks traded higher toward the end of trading, with the Dow Jones gaining 575 points on Thursday.

The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage.

The U.S. Food and Drug Administration (FDA) announced 510(k) clearance (pre-market notification) of Apyx Medical’s (NASDAQ: APYX) Renuvion Dermal Handpiece for specific dermal resurfacing procedures.

Apyx Medical Corporation (NASDAQ:APYX) has FDA received 510(k) clearance for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures.  The Renuvion Dermal Handpiece is indicated for dermatological procedures to treat moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III. The company expects…

U.S. stocks traded higher midway through trading, with the Dow Jones gaining around 1.5% on Thursday.

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).