The Latest Breaking News from FDA

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States, cities, counties and tribal governments across the nation will soon receive a windfall through several major opioid settlements. Drug distributors and manufacturers, including Purdue Pharma and the Sackler family members who own it, will relinquish a total of about US$32 billion for their role in the overdose crisis. Other…

In Hawaii, senators approved two identical measures to form a psilocybin working group, Marijuana Moment reported. The goal of the group would be to explore the therapeutic potential of the psychedelic, but the resolutions were amended and patient access will be contingent on federal approval of psilocybin. Both proposals —sponsored by…

Along with the psychedelic renaissance came a new type of drug: second generation psychedelics. Developed from classic psychedelics molecules, these upgraded compounds could offer improved therapeutic profiles with reduced side effects. For some companies in the psychedelics space, second generation psychedelics could be the key to success in an increasingly…

The Food and Drug Administration on Thursday rejected a lung cancer drug Eli Lilly tested only in China, but LLY stock inched higher.

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The Food and Drug Administration meets next week to review a closely watched drug for ALS, or Lou Gehrig’s disease, following months of lobbying by patient groups and congressional lawmakers

Pfizer and Moderna seek approval for second ‘booster’ doses as White House warns US has exhausted funding to buy more shots

The FDA has granted Breakthrough Therapy Designation to Pfizer Inc's (NYSE:PFE) respiratory syncytial virus (RSV) vaccine candidate (PF-06928316 or RSVpreF) to prevent lower respiratory tract disease caused by RSV in 60 years of age or older. The positive results primarily inform the FDA decision of Phase 2a study evaluating the safety, immunogenicity, and efficacy…