Astellas Submits New Drug Application for Zolbetuximab in Japan
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 -- (Healthcare Sales & Marketing Network) -- Astellas Pharma Inc. (TSE: 4503, Presid... Biopharmaceuticals, Oncology, Regulatory Astellas Pharma, zolbetuximab, gastric cancer, gastroesophageal cancer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 9, 2023 Category: Pharmaceuticals Source Type: news

Vyluma Announces FDA Acceptance of New Drug Application For NVK002, Its Novel Investigational Treatment For Pediatric Myopia
Bridgewater, NJ– June 6, 2023– Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 6, 2023 Category: Drugs & Pharmacology Source Type: news

SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA
FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review New PDUFA Date Set to November 27, 2023 STAMFORD, Conn., June 05, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 5, 2023 Category: Drugs & Pharmacology Source Type: news

Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma
BRISBANE, Calif., June 04, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the“Company”), a clinical-stage biopharmaceutical Company dedicated to developing and commercializing targeted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 4, 2023 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb ’s Application for Repotrectinib for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer
Application based on results from the registrational TRIDENT-1 trial, in which repotrectinib demonstrated high response rates and durable responses in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer If... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2023 Category: Drugs & Pharmacology Source Type: news

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2023 Category: Drugs & Pharmacology Source Type: news

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
RARITAN, NJ, May 30, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.[1] The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT si...
Source: Johnson and Johnson - May 30, 2023 Category: Pharmaceuticals Source Type: news

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat
FDA denies formal dispute resolution, but outlines path to resubmit NDA for dialysis-dependent patients without new clinical studies Akebia plans to request Type A meeting and then resubmit NDA CAMBRIDGE, Mass., May 30, 2023 /PRNewswire/ --... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 30, 2023 Category: Drugs & Pharmacology Source Type: news

Takeda and Hutchmed Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review
OSAKA, Japan, CAMBRIDGE, Massachusetts, HONG KONG, SHANGHAI&, FLORHAM PARK, New Jersey, Friday May 26, 2023– Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 26, 2023 Category: Drugs & Pharmacology Source Type: news

Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma
SAN CARLOS, Calif., May 26, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 26, 2023 Category: Drugs & Pharmacology Source Type: news

Phathom Pharmaceuticals Resubmits Vonoprazan Erosive GERD New Drug Application to FDA
FLORHAM PARK, N.J., May 23, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced that it has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 23, 2023 Category: Drugs & Pharmacology Source Type: news

Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for Lumisight ™ Optical Imaging Agent for Breast Cancer
NEWTON, Mass., May 22, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 22, 2023 Category: Drugs & Pharmacology Source Type: news

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