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Biogen and Sage Therapeutics Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
on December 6, 2022 at 2:11 am
Zuranolone is being evaluated as a short course, rapid-acting, oral medication for major depressive disorder (MDD) and postpartum depression (PPD) Cambridge, Mass. – Dec. 6, 2022– Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics...
Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease
on November 29, 2022 at 1:11 am
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 29, 2022-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an...
Sarepta Therapeutics Announces That U.S. FDA has Accepted for Filing and Granted Priority Review for the Biologics License Application for SRP-9001, Sarepta’s Gene Therapy for the Treatment of Ambulant Individuals with Duchenne Muscular Dystrophy
on November 28, 2022 at 4:11 am
Regulatory action date of May 29, 2023 SRP-9001 would be the first gene therapy for Duchenne, a one-time treatment designed to treat the underlying cause of DMD by delivering a functional shortened dystrophin to muscle CAMBRIDGE, Mass., Nov....
Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poziotinib
on November 25, 2022 at 1:11 am
Immediately de-prioritizes poziotinib program, accelerates cost reductions, including 75% reduction in R&D related workforce Spectrum to explore strategic alternatives for the poziotinib program, including partnerships and business...
GSK Provides an Update on Blenrep (belantamab mafodotin-blmf) US Marketing Authorization
on November 22, 2022 at 10:11 pm
London, UK, 22 November 2022 -- GSK plc (LSE/NYSE: GSK) today announced it has initiated the process for withdrawal of the US marketing authorization for Blenrep following the request of the US Food and Drug Administration (FDA). This request was...
Opiant Pharmaceuticals Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose
on November 22, 2022 at 1:11 am
SANTA MONICA, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration...
U.S. FDA Accepts for Priority Review the Biologics License Application for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma
on November 21, 2022 at 10:11 pm
The application is supported by data from EPCORE™ NHL-1 Phase 1/2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's...
Iovance Biotherapeutics Provides Update on Biologics License Application Submission for Lifileucel in Advanced Melanoma
on November 18, 2022 at 12:11 am
BLA Submission Ongoing with U.S. Food and Drug Administration SAN CARLOS, Calif., Nov. 18, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) today announced that its ongoing rolling Biologics License Application (BLA)...
Iveric Bio Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy
on November 17, 2022 at 2:11 am
Designation based on 12-month primary endpoint data from GATHER pivotal trials Avacincaptad pegol (ACP) is the only investigational product for treatment of GA to achieve two positive phase 3 pivotal trials with statistical significance In...
UCB Announces U.S. FDA Acceptance of New Drug Application and EMA MAA Validation for Zilucoplan for the Treatment of Generalized Myasthenia Gravis in Adult Patients
on November 14, 2022 at 2:11 am
New drug application (NDA) for zilucoplan seeks approval for the treatment of generalized myasthenia gravis (gMG) in adult patients who are acetylcholine receptor antibody positive (AChR-Ab+) Acceptance by U.S. Food and Drug Administration (FDA)...
Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease
on November 11, 2022 at 2:11 am
IPX203 could offer people living with Parkinson’s disease a longer duration of symptom control with less frequent dosing compared to IR CD/LD treatment The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 30,...
BioLineRx Announces U.S. FDA Acceptance of New Drug Application for Aphexda (motixafortide) in Stem Cell Mobilization
on November 10, 2022 at 9:11 pm
PDUFA target action date set for September 9, 2023 NDA submission based on GENESIS Phase 3 trial data that met all primary and secondary endpoints with a high level of statistical significance Company advancing preparations for robust commercial...
Iveric Bio Announces Submission of First Part of NDA for Rolling Review of Avacincaptad Pegol for the Treatment of Geographic Atrophy
on November 3, 2022 at 11:11 pm
PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov. 3, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the first part of its New Drug Application (NDA) for rolling review of...
Genmab Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL) and Diffuse Large B-Cell Lymphoma (DLBCL)
on October 28, 2022 at 12:10 am
Genmab has Submitted Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) for epcoritamab European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for epcoritamab submitted by AbbVie The...
Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy
on October 27, 2022 at 2:11 am
Pratteln, Switzerland, and Rockville, MD, USA, October 27, 2022 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application (NDA) to the U.S. Food...
Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus
on October 27, 2022 at 12:10 am
Foster City, Calif., October 27, 2022 – The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for bulevirtide, an investigational entry-inhibitor for the...
Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review
on October 26, 2022 at 11:10 pm
If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter FDA advised that they are not currently planning to hold an Advisory...
Novaliq Announces FDA Acceptance of the New Drug Application for CyclaSol for the Treatment of Dry Eye Disease
on October 24, 2022 at 9:10 pm
PDUFA target action date is June 8, 2023 HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the...
Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen
on October 17, 2022 at 11:10 pm
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023 CAMBRIDGE, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has...
Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
on October 17, 2022 at 1:10 am
BURLINGTON, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that...