J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.
Despite lingering skepticism about whether interim data from an ongoing cardiovascular trial would be enough to convince FDA to clear an NDA, Johnson & Johnson’s Janssen Pharmaceuticals Inc. unit gained approval for its type 2 diabetes treatment Invokana (canagliflozin) on March 29.
The drug has been tested in nine clinical trials in more than 10,000 patients, both as a standalone therapy, and...
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
