Firm announces three-month user fee extension for first-line melanoma claim for Opdivo, but the firm’s statement suggests a silver lining.
In announcing the regulatory delay for Bristol-Myers Squibb Co.’s first-line melanoma filing for Opdivo (nivolumab), the company appears to be signaling that it expects approval in both BRAF wild-type and mutant patients – which would be bad news for BRAF inhibitors.
The supplemental Biologics License Application (sBLA) for previously untreated advanced melanoma was accepted for review in April and has been...
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
