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 ...
Monthly Prescribing Reference

FDA Grants Review of Lorundrostat NDA for Add-on Hypertension Therapy

A Prescription Drug User Fee Act target date of December 22, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ...
Pharmaceutical Technology on MSN

FDA accepts Beren Therapeutics’ NDA for Niemann-Pick disease

The submission includes data indicating a meaningful survival benefit for infantile-onset NPC patients treated with adrabetadex.
Morningstar

Ascelia Pharma Announces FDA Acceptance of Orviglance New Drug Application for Review

MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Monthly Prescribing Reference

Novel Low-Sodium Oxybate Formulation Under FDA Review

The FDA has set a Prescription Drug User Fee Act target date of June 20, 2026 for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for TRN ...
Morningstar

Full Year and Q4 Report 2025: FDA Accepts Orviglance NDA for Review

"Following the Orviglance New Drug Application (NDA) submission in September 2025, we continued to make solid progress in Q4. In November, we received the US Food and Drug Administration (FDA) Day 74 ...
The American Journal of Managed Care

FDA Issues CRL to NDA for Dasynoc in CML and ALL

The FDA's complete response letter for Dasynoc was due to manufacturing issues, delaying its approval for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) treatment. Dasynoc, a ...
Nasdaq

Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation

Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation FDA acceptance starts the review process and sets ...
Briefing.com

Axsome Therapeutics Higher on FDA Catalysts: AXS-05 Priority Review and AXS-12 NDA Support (AXSM)

Axsome Therapeutics (AXSM) is trading sharply higher after announcing this morning that the FDA accepted for filing its supplemental New Drug Application (sNDA) for AXS-05 in Alzheimer's disease (AD) ...
Insider Monkey

Celcuity Inc. (CELC)’s FDA NDA for Gedatolisib Accepted Under RTOR, Accelerating Review

We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Celcuity Inc. is one of them. Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company developing ...