The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
Psychedelic drug development can still benefit from the FDA Commissioner’s National Priority Review Voucher Pilot Program, though the CNPV designation was not given to Compass Pathways’ synthetic ...
A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...
The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a streamlined pathway for bespoke therapies that could address unmet medical needs.
The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...
Creating a drug that might help treat or cure a health condition in humans is a long, complex process. After developing a ...
FDA unveils pathway ultra-rare disease therapies to approve gene-editing and RNA treatments when trials are unfeasible for small populations.
The FDA granted orphan drug designation to deupirfenidone, also known as LYT-100, for treating patients with idiopathic pulmonary fibrosis, according to a press release from PureTech Health.The ...
At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.
Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
Where FDA breakthrough devices stand through 2025: growth, authorizations, leading specialties, AI trends, and qualification pathways explained.
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