Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine
January 2024 PDUFA date expected
If approved, STS101 would become the only DHE product evaluated in a randomized, placebo-controlled trial (the SUMMIT trial) against modern outcome measures recommended by both the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 18, 2023 Category: Drugs & Pharmacology Source Type: news
Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma
Fort Lee, N.J., May 17, 2023 - Elevar Therapeutics, Inc., a wholly owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 17, 2023 Category: Drugs & Pharmacology Source Type: news
Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer ’s Disease
PRINCETON, NJ and DEERFIELD, IL– May 10, 2023– Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Turns Down TransCon PTH; Black Market Hormones; Pandemic Thyroid Tumors
(MedPage Today) -- Denmark's Ascendis Pharma announced that the FDA declined to approve the company's new drug application for the hypoparathyroidism drug palopegteriparatide (TransCon PTH) due to manufacturing concerns.
Workdays missed because... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - May 2, 2023 Category: Endocrinology Source Type: news
FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults
April 28, 2023 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Abilify Asimtufii® (aripiprazole)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2023 Category: Drugs & Pharmacology Source Type: news
Arbutus Biopharma shares decline as FDA puts hold on drug study application
The Bucks County company's investigational new drug application is for an experimental therapy to treat hepatitis B infections. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 26, 2023 Category: American Health Authors: John George Source Type: news
bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events
SOMERVILLE, Mass.--(BUSINESS WIRE)--Apr. 24, 2023-- bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 24, 2023 Category: Drugs & Pharmacology Source Type: news
Janssen Marks First Approval Worldwide for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
BEERSE, Belgium, 21 April 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.2Prostate cancer is the most common cancer in men in Europe, and the sixth-highest cause of cancer-related death worldwide.1...
Source: Johnson and Johnson - April 21, 2023 Category: Pharmaceuticals Tags: Innovation Source Type: news
Industry Resources
Information to assist the drug manufacturing industry in the development of generic drugs and the completion of abbreviated new drug applications (ANDAs) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 21, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA
TOKYO& BASKING RIDGE, N.J.--(BUSINESS WIRE)-- April 21, 2023 -- Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 21, 2023 Category: Drugs & Pharmacology Source Type: news
Johnson & Johnson Reports Q1 2023 Results
New Brunswick, N.J. (April 18, 2023) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2023. “Our first quarter results demonstrate strong performance across all three segments of our business and reflect the dedication of Johnson & Johnson colleagues around the world,” said Joaquin Duato, Chairman of the Board and Chief Executive Officer. “With this momentum, I look forward to the remainder of the year, one filled with exciting catalysts that will create both near- and long-term value for patients and all of our stakeholders.”OVERALL FINANCIAL RESULTSQ1($ in Millions, except EPS)2...
Source: Johnson and Johnson - April 18, 2023 Category: Pharmaceuticals Tags: Financial Source Type: news
Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for Xphozah (tenapanor)
WALTHAM, Mass., April 18, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 18, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab
INDIANAPOLIS, April 13, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 13, 2023 Category: Drugs & Pharmacology Source Type: news
Pharma CMOs may feel heat as USFDA approves fewer new drugs, GlobalData report says
Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, stated GlobalData in its latest report - ‘New Drug Approvals and Their Contract Manufacture – 2023 Edition’. The report said that USFDA’s new molecular entity approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop, which meant fewer commercial-scale production contracts for the most i nnovative products. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 6, 2023 Category: Pharmaceuticals Source Type: news
Parathyroid Drug on Hold; FreeStyle Libre Safety Note; Levothyroxine Overprescribed?
(MedPage Today) -- The FDA "identified deficiencies" in Ascendis Pharma's new drug application for its hypoparathyroidism drug palopegteriparatide (TransCon PTH), putting new labeling and post-marketing discussions on hold for now, the developer... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - April 5, 2023 Category: Endocrinology Source Type: news
