Scholar Rock submitted its BLA of apitegromab for the treatment of patients with Spinal Muscular Atrophy with a request for ...

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A Tucson environmental group is suing the U.S. Food and Drug Administration for failing to set limits on PFAS, also known as ...

Abeona Therapeutics Inc.'s promising gene therapy for RDEB, potential FDA approval, undervalued stock, and key risks. Click ...

A menthol ban is something that the US Food and Drug Administration under the Biden administration had said was a “top priority.” It sent the final version of its rule banning menthol cigarettes and ...

The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...

Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...

A drug receiving Fast Track designation also may be eligible for Accelerated Approval and Priority Review if relevant criteria are met ... the potential of the FORCE platform, the anticipated timeline ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

The need of the hour, therefore, is to compress the acquisition timelines so that a new system is inducted ... The product must take priority over the process. General Manoj Mukund Naravane PVSM AVSM ...

2 In combination, the application for acalabrutinib previously received priority review—which shortens the FDA’s review period from 10 to 6 months—and orphan drug designations, meaning there ...

This isn't the first time the FDA has wielded the Delaney Clause—similar actions were taken against certain synthetic flavors in 2018—but the long timeline highlights the complexities of ...