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.
- Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Applicationon June 27, 2022 at 4:06 am
CAMBRIDGE, Mass., June 27, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA)...
- Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitoron June 27, 2022 at 1:06 am
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 27, 2022-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational,...
- Sierra Oncology Announces Submission of New Drug Application for Momelotinib to US Food & Drug Administrationon June 17, 2022 at 10:06 pm
Submission seeks approval of momelotinib for the treatment of myelofibrosis SAN MATEO, Calif.--(BUSINESS WIRE) June 17, 2022 -- Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver...
- Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndromeon June 13, 2022 at 5:06 am
DUBLIN, June 13, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced the resubmission of the Company's New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the...
- Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALSon June 3, 2022 at 3:06 am
New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data CAMBRIDGE, Mass.--(BUSINESS WIRE) June 3, 2022 -- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”)...
- Eagle Pharmaceuticals Announces Submission of New Drug Application to U.S. Food and Drug Administration for Landiolol, a Beta-1 Adrenergic Blockeron June 1, 2022 at 9:06 pm
Submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter Expected approval mid-year 2023, if accepted by FDA for...
- Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failureon May 31, 2022 at 2:06 am
The Woodlands, Texas, May 31, 2022 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale...
- Reata Pharmaceuticals Announces FDA Filing Acceptance and Priority Review Designation for the NDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxiaon May 26, 2022 at 5:05 am
Friedreich’s Ataxia is a Rare, Progressive, Life-Shortening, Neuromuscular Disease that Affects Approximately 5,000 Patients in the United States Application Assigned a PDUFA Date of November 30, 2022 If Approved, Omaveloxolone Would...
- Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitison May 25, 2022 at 4:05 am
FLORHAM PARK, N.J., May 25, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the U.S. Food...
- Verrica Receives Complete Response Letter from the FDA for its NDA for VP-102on May 24, 2022 at 3:05 am
Verrica has been advised that PAI (Pre-Approval Inspection) was conducted at Sterling and is not aware of any reported observations related to the PAI of VP-102 operations Review Division had advised Verrica that the review of NDA was completed...
- US FDA Accepts for Review Biohaven's New Drug Application (NDA) Filing of Intranasal Zavegepant for the Treatment of Migraineon May 23, 2022 at 5:05 am
If approved, zavegepant nasal spray would be the only FDA-approved CGRP receptor antagonist in an intranasal formulation, giving patients a new treatment option that provides ultra-rapid pain relief in as little as 15 minutes that lasts...
- ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Reviewon May 23, 2022 at 4:05 am
WALTHAM, Mass.--(BUSINESS WIRE)-- May 23, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has...
- AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Diseaseon May 20, 2022 at 4:05 am
If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of "On" time without...
- Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbilon May 17, 2022 at 5:05 am
SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with the U.S. Food & Drug Administration (FDA) and...
- Travere Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathyon May 16, 2022 at 10:05 pm
PDUFA target action date of November 17, 2022 SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of its New...
- scPharmaceuticals Inc. Announces FDA Acceptance of Furoscix New Drug Applicationon May 16, 2022 at 5:05 am
PDUFA action date set for October 8, 2022 BURLINGTON, Mass., May 16, 2022 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize...
- Update on U.S. FDA Review of Biologics License Application (BLA) for Bimekizumab - Complete Response Letteron May 13, 2022 at 10:05 pm
Brussels (Belgium), 13th May 2022 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA)...
- Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathwayon May 9, 2022 at 1:05 am
TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, May 9, 2022 -- CEO: Michel Vounatsos, "Biogen") announced today that Eisai has...
- Hutchmed Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumorson May 4, 2022 at 3:05 am
Hong Kong, Shanghai & Florham Park, NJ — Monday, May 2, 2022: Hutchmed (China) Limited (“Hutchmed” or the “Company”) (Nasdaq/AIM:HCM; HKEX:13) announced that the U.S. Food and Drug Administration (“FDA”...
- Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)on May 2, 2022 at 8:05 pm
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023 CAMBRIDGE, Mass. – May 2, 2022 – Sage...