FDA Extends Review Timeline for Praxis’ Relutrigine NDA

Detailed price information for Praxis Precision Medicines Inc (PRAX-Q) from The Globe and Mail including charting and trades.
RAPS

FDA details review timelines as facility assessment-related CRLs pile up

In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when ...

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 ...

Palvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules ...
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 ...
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Bayer gets FDA priority review for asundexian NDA in stroke prevention

Bayer BAYRY announced that the FDA has accepted its new drug application (NDA) for its investigational, once-daily, oral Factor XIa inhibitor, asundexian, for preventing ischemic stroke in patients ...
Morningstar

Egetis Announces FDA Acceptance and Priority Review of NDA for Emcitate(R) (tiratricol) for MCT8 Deficiency

STOCKHOLM, SE / ACCESS Newswire / March 27, 2026 / Egetis Therapeutics (STO:EGTX) - Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (NASDAQ Stockholm:EGTX), today announced that the U.S.
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Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines

WASHINGTON, April 9, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today highlighted a legislative proposal contained in the FDA's FY 2027 Congressional Budget Justification.

CORT Stock Hits Highest Levels In 2026 – Cushing’s Syndrome Drug NDA Resubmission Extends 5-Session Rally

Corcept said it will resubmit the new drug application in the coming weeks after positive talks with the U.S. Food and Drug Administration.
Nasdaq

Exelixis: FDA To Review NDA For Zanzalintinib-atezolizumab Combination

(RTTNews) - Exelixis, Inc. (EXEL) announced that its New Drug Application for zanzalintinib, in combination with atezolizumab, has been accepted for review in the U.S. for the treatment of adult ...