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Janssen and Bayer are facing yet another lawsuit over alleged gastrointestinal bleeding with their blood thinner Xarelto, this time from 25 plaintiffs in six states. Read More
Two FDA advisory committees voted 23 to 1 on Thursday not to recommend approval of Purdue Pharma’s NDA for Avridi, saying the public health benefits of the abuse-deterrent opioid don’t outweigh the risks to patients posed by the effect of food intake. Read More
A pair of U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act Wednesday. Read More
An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds on Sept. 1 after the FDA received reports of adverse events. Read More
Otsuka Pharmaceutical and Proteus Digital Health announced Thursday FDA acceptance of their first-of-its-kind digital medicine NDA combining Abilify with a digital tracking mechanism. Read More
Amneal Pharmaceuticals can begin marketing its generics version of Allergan’s Alzheimer’s extended-release drug Namenda XR on Jan. 31, 2020, pending FDA approval, under an agreement reached by the two firms. Read More
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More