Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease
Additional Trial Required to Demonstrate Positive Effect on the Treatment of Ocular Symptoms in Dry Eye Disease Special Protocol Assessment Submitted on November 16, 2023 for Dry Eye Disease Chamber Crossover Clinical Trial Proposed Trial... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 27, 2023 Category: Drugs & Pharmacology Source Type: news

Pfizer and Astellas & #039; XTANDI ® approved by U.S. FDA in earlier prostate cancer treatment setting
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. (Source: World Pharma News)
Source: World Pharma News - November 21, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Merck Provides Update on FDA Advisory Committee Meeting Evaluating Gefapixant
RAHWAY, N.J., Nov. 17, 2023– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the outcome of the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting, which... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 17, 2023 Category: Drugs & Pharmacology Source Type: news

Summary of NDA Approvals & Receipts, 1938 to the present
Running account of number of New Drug Applications received and approved since 1938. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 8, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellitus
November 06, 2023, Ahmedabad, India --  Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as " Zydus " ) today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 6, 2023 Category: Drugs & Pharmacology Source Type: news

Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA
ROCKVILLE, Md., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 2, 2023 Category: Drugs & Pharmacology Source Type: news

CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel (exa-cel) for Severe Sickle Cell Disease
Exa-cel PDUFA target action date is December 8, 2023 for severe sickle cell disease (SCD) ZUG, Switzerland and BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) today announced the completion of the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 31, 2023 Category: Drugs & Pharmacology Source Type: news

X4 Pharmaceuticals Announces FDA Acceptance with Priority Review of U.S. NDA for Mavorixafor in WHIM Syndrome
BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) --X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the United States Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 31, 2023 Category: Drugs & Pharmacology Source Type: news

Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
BRISBANE, Calif., Oct. 30, 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 - October 30, 2023 Category: Drugs & Pharmacology Source Type: news

Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease
CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 25, 2023 Category: Drugs & Pharmacology Source Type: news

Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil
Submission seeks approval for treatment of an abnormal heart rhythm, Paroxysmal Supraventricular Tachycardia or PSVT Comprehensive data package includes positive results from pivotal Phase 3 RAPID trial which Company believes demonstrates... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 24, 2023 Category: Drugs & Pharmacology Source Type: news

Lupin gets USFDA nod to market generic antifungal tablets
The approval granted by the US Food and Drug Administration (USFDA) for the abbreviated new drug application of Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg, Lupin said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 23, 2023 Category: Pharmaceuticals Source Type: news

FDA Approves Zituvio (sitagliptin) for the Treatment of Adult Patients with Type 2 Diabetes Mellitus
AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as ' Zydus ' ) today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2023 Category: Drugs & Pharmacology Source Type: news

Sun Pharma files new drug application with USFDA for investigational medicine to treat alopecia
The new drug application filing for deuruxolitinib with the USFDA is based on two pivotal Phase III trials, which included over 1,200 patients, across more than 135 clinical trial sites, the company said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 6, 2023 Category: Pharmaceuticals Source Type: news

Sun Pharma Announces US FDA Filing Acceptance of New Drug Application for Deuruxolitinib
Mumbai, INDIA and Princeton, N.J., October 06, 2023– Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715,“Sun Pharma” and includes its subsidiaries or associate companies) today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 6, 2023 Category: Drugs & Pharmacology Source Type: news