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Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator, and the topline numbers didn’t come with context indicating their statistical validity. Read More
The FDA’s Antimicrobial Drugs Advisory Committee gave a 14-1 thumbs-up yesterday for Cidara Therapeutics’ rezafungin, an investigational injection intended to treat candidemia and invasive candidiasis in adults who have no other treatment options. Read More
In a clear sign that the FDA is raising the bar for accelerated approvals, the agency has declined to grant Accelerated Approval for donanemab — Eli Lilly’s entry into the antiamyloid antibody race — saying there isn’t enough long-term data to support such a move. Read More
Rybelsus had been indicated only as an adjunct treatment, along with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Read More
Airsupra is the result of a collaboration between AstraZeneca and UK-based Avillion, a drug development company that conducted the clinical studies. Read More
More than half of the new drugs the FDA approved in 2022 were aimed at rare diseases, according to the Center for Drug Evaluation and Research’s (CDER) just-released New Drug Therapy Approvals report. Read More
On the heels of nabbing accelerated approval of its Alzheimer’s therapy Leqembi (lecanemab), Eisai has filed for full approval of the drug in patients with mild cognitive impairment (MCI) or mild dementia and confirmed presence of amyloid beta plaque in the brain. Read More
Eisai’s antiamyloid antibody lecanemab has won FDA Accelerated Approval for treatment of Alzheimer’s disease (AD) and, under the trade name Leqembi, will be available the week of Jan. 23. Read More