Approach is modeled after the interdisciplinary review team established more than a decade ago to review data on QT interval effects, FDA says; at a recent Duke meeting on assessing off-target pressor effects, discussion focused on lessons learned in the QT space that could be applied to studying blood pressure effects.
The US FDA intends to adopt a more systematic approach to advice and data reviews on the blood pressure effects of new drugs that is modeled after its evaluation of pro-arrhythmic effects.
Norman Stockbridge, director of FDA’s Division of Cardiovascular and Renal Products, said the agency is looking to standardize its approach...
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 An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.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.
