‘Lack of Substantial Evidence’ Leads to FDA Rejection of Aldeyra Dry Eye Disease Drug

Frank Vinluan / medcitynews - Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but the drug’s mixed record in clinical testing warrants exploration about the reasons for failure, which could identify the appropriate patients for the eye dr…

AI Summary: The FDA has rejected Aldeyra’s reproxalap application, citing a lack of substantial evidence—marking the company’s third setback. Regulators did not demand a fresh, large trial but flagged inconsistent results, prompting investor angst and a slide in the stock. The decision underscores the gap between hopeful early data and regulatory standards.

F.D.A. Investigates 7 E. Coli Illnesses as Raw Dairy Farm Denies Any Link

Christine Hauser and Alice Callahan / nytimes - The outbreak has sickened people in California, Texas and Florida. The agency said Cheddar cheese products from Raw Farm are “the likely source,” but the company denies it and has not recalled them.

AI Summary: Federal investigators are probing seven E. coli infections across multiple states tied to cheddar cheese produced from raw milk. The implicated Raw Farm cheddar is the suspected source; the producer denies responsibility as public health officials trace exposures and warn consumers while urging caution around unpasteurized dairy.