FDA Grants Rolling Review of Palvella’s QTORIN™ Rapamycin NDA for Microcystic Lymphatic Malformations

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections ...
InvestorsHub on MSN

Palvella shares advance after FDA grants rolling review for rare disease therapy

Palvella Therapeutics Inc (NASDAQ:PVLA) shares gained 5% in premarket trading on Monday after the company announced that the U.S. Food and Drug Administration had granted rolling review status to its ...

BIO CEO says more consistency needed in FDA review process

By Deena Beasley SAN DIEGO, June 23 (Reuters) - U.S. biotechnology industry trade group BIO worked with the Food and Drug ...
RAPS

FDA publishes NDA filing checklist to avoid application derailments

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...
Morningstar

Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug ...
Morningstar

Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Adrabetadex for the Treatment of Infantile-Onset Niemann-Pick Disease, Type C

Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, announced that the U.S. Food and Drug Administration ...
Psychiatry Advisor

FDA Streamlines Review Process for Premarket Tobacco Applications

The FDA Center for Tobacco Products is utilizing a real-time communication process to decrease application review times.
GlobalData on MSN

FDA grants priority review for Sanofi’s venglustat NDA

The decision is anticipated by 25 November 2026.
Business Insider

BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9

- Accepted for Priority Review with PDUFA target action date of November 27, 2026, and poised to launch upon approval; being granted Priority Review by the FDA reiterates the serious unmet need for ...
RAPS

FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The ...

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have ...