Just in time for the holidays, on December 15, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued an untitled letter (the “Letter”) to Karuna ...
As the FDA steadily churns out a stream of untitled letters chastising pharmaceutical advertisers’ direct-to-consumer materials, a commercial for Bristol Myers Squibb’s Cobenfy is taking its turn in ...
Bristol Myers Squibb and its subsidiary Karuna Therapeutics received the latest Untitled Letter from the Food and Drug Administration earlier this week. In a letter issued on December 15 to Nicole Van ...
Bristol Myers Squibb (BMS) has delayed the data readout from the Phase III ADEPT-2 trial of Cobenfy (xanomeline/trospium chloride) after identifying site irregularities. The trial (NCT06126224) is ...
Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.
Bristol Myers Squibb BMY recently announced that it will continue the phase III ADEPT-2 study on Cobenfy in psychosis associated with Alzheimer's disease. The decision to continue the study follows a ...
The drug giant is testing Cobenfy, one of its most important drugs, in Alzheimer's psychosis but needs to enroll more patients in the trial Bristol-Myers Squibb pushed back the readout for a key drug ...
The phase 3 comeback story Bristol Myers Squibb investors were eagerly anticipating is not to be—at least not this year. The highly anticipated Adept-2 study will not read out by year-end as ...
The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in subjects with psychosis associated with Alzheimer’s disease ...
Shares of Bristol Myers Squibb BMY gained 5.62% after the company announced the continuation of the phase III ADEPT-2 study on Cobenfy in psychosis associated with Alzheimer's disease. The news ...
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the New Drug Application ...