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The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible ...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

FDA Grants Fast Track Designation to VS-7375 for KRAS G12D–Mutated NSCLC

FDA fast-tracks VS-7375, an oral KRAS G12D inhibitor, opening new hope for pretreated advanced NSCLC and fueling pivotal ...
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 ...
JD Supra

FDA Calls for Industry to Strengthen Recall Programs

On December 15, 2025, the U.S. Food and Drug Administration (FDA) issued a letter to industry emphasizing the importance of “effective recall compliance across the food supply chain” and reminding ...
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 ...
Corpus Christi Caller-Times

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 ...
BioSpaceOpinion

Opinion: The next FDA commissioner must be a champion for gene therapies

The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene ...
Hosted on MSN

FDA declines to issue specific guidance on health programs' foreign drug imports

The Food and Drug Administration responded to a health policy group requesting clear enforcement of alternative funding programs, or AFPs. The agency reiterated its regulation against the foreign ...
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 ...
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 ...