RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
JD Supra

Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, and Postapproval Evidence Generation

FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene ...
RAPS

FDA addresses establishment of inspection programs for injectables

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible ...
Medical Xpress

FDA unveils drugs to receive expedited review in support of 'national priorities'

The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...
Commercial Appeal

FDA-Authorized Expanded Access Programs Utilizing Jaguar Health’s Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...
JD Supra

FDA’s Office of Dietary Supplement Programs Signals Key Enforcement and Policy Priorities for the Year Ahead

During a recent industry webinar, Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs (“ODSP”) within the U.S. Food and Drug Administration (“FDA”), outlined the agency’s 2026 ...
MarketWatch

Regenxbio Shares Plunge on FDA Pausing Two Drug Development Programs

Shares of Regenxbio plunged after the Food and Drug Administration placed clinical holds on two drug development programs after a five-year-old participant in one study developed an intraventricular ...
Hosted on MSN

FDA’s uniQure reversal unlikely to impact Regenxbio’s programs, says Stifel

Stifel analyst Annabel Samimy says that the news regarding FDA’s reversal on the approvability of uniQure’s (QURE) AMT-130 on Phase 1/2 data on the surface injects another layer of uncertainty into ...