Drugs.com - New Drug Applications New drug applications news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
- Regeneron Provides Update on Biologics License Application for Odronextamabon March 25, 2024 at 7:03 pm
TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application...
- Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosaceaon March 18, 2024 at 8:03 pm
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and...
- U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinibon March 13, 2024 at 11:03 pm
MIAMI--(BUSINESS WIRE) March 13, 2024 --Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic...
- Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of Lumisight in the Detection of Cancerous Tissue During Breast Conserving Surgeryon March 6, 2024 at 2:03 am
NEWTON, Massachusetts March 6, 2024 – Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer, today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and...
- SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PNon March 4, 2024 at 3:03 am
STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling...
- Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type Con March 4, 2024 at 3:03 am
CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has extended the review period...
- Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemiaon February 28, 2024 at 2:02 am
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical...
- Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophreniaon February 27, 2024 at 7:02 pm
BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the...
- BeiGene’s Biologics License Application for Tevimbra (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDAon February 27, 2024 at 12:02 am
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE) February 27, 2024 -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has...
- Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactamon February 23, 2024 at 10:02 pm
Malvern, PA, and Parsippany, NJ – February 23, 2024 – Venatorx Pharmaceuticals (Venatorx) and Melinta Therapeutics (Melinta) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL)...
- Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Reviewon February 21, 2024 at 7:02 pm
TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for...
- FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse gliomaon February 20, 2024 at 1:02 am
Boston, MA, Suresnes, France, February 20 2024 – Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New...
- Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Canceron February 19, 2024 at 8:02 pm
Application based on results from the TROPION-Lung01 Phase III trial If approved, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan may be the first TROP2-directed antibody drug conjugate for patients with lung cancer 19 February...
- Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EUon February 14, 2024 at 3:02 am
Zug, Switzerland – February 14, 2024 – Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents...
- Citius Pharmaceuticals Resubmits the Biologics License Application of Lymphir (denileukin diftitox) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-Cell Lymphomaon February 13, 2024 at 3:02 am
CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products...
- FDA Accepts Xspray Pharma’s NDA-Resubmission for Dasynocon February 12, 2024 at 3:02 am
Stockholm, Sweden – 2024-02-12 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a...
- Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSDon February 9, 2024 at 4:02 am
SAN JOSE, Calif., Feb. 9, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration ("FDA") has...
- Amneal Announces Complete Response Resubmission for IPX203 New Drug Applicationon February 8, 2024 at 4:02 am
BRIDGEWATER, N.J., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug...
- Bridgebio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)on February 5, 2024 at 4:02 am
Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application Marketing Authorization Application accepted by the European Medicines...
- Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adultson January 30, 2024 at 1:01 am
ST. LOUIS, MO—(BUSINESS WIRE)—Jan. 30, 2024—Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the U.S. Food and...