PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX₁₀₀’s New Drug Application

FDA Grants $4.3 Million Small Business Waiver, Enabling Focus on Commercialization PreparationsCompany On Track to Initiate NDA Submission by the ...
Zacks Investment Research on MSN

ALDX crashes 71% as FDA issues third CRL for dry eye disease drug NDA

Shares of Aldeyra Therapeutics ALDX plunged 70.7% on Tuesday after the company announced receiving a Complete Response Letter (CRL) from the FDA for a third time for the new drug application (NDA) ...
GlobalData on MSN

FDA issues CRL to Aldeyra’s reproxalap drug application

During the review process, the FDA provided label drafts in December 2025 and March 2026.

Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)

Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration ...
Seeking Alpha

Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)

LOS ALTOS, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced ...

Gyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announ ...
Seeking Alpha

Disc Medicine Announces Submission of New Drug Application (NDA) to US FDA for Accelerated Approval of Bitopertin for Patients with Erythropoietic Protoporphyria (EPP)

Disc is seeking accelerated approval and priority review of its NDA submission FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 ...

Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and ...

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced ...
The Cardiology Advisor

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

The FDA accepts the NDA for lorundrostat, a selective aldosterone synthase inhibitor, for adults with uncontrolled or resistant hypertension.
Morningstar

VivaVision Biotech Receives Positive Written Feedback from FDA - VVN461HD New Drug Application (NDA) Requires Only a "Single Phase III" Pivotal Clinical Study in the U.S. for ...

WENZHOU, China, Jan. 6, 2026 /PRNewswire/ -- Recently, VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs, ...
Times Argus

Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV)

Takeda ( TSE:4502/NYSE:TAK) and Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist”) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking ...