MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD
SAN JOSE, Calif. , Dec. 12, 2023 /PRNewswire/ -- MAPS Public Benefit Corporation ( " MAPS PBC " ), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced the submission of a new drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 12, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Accepts for Review Resubmitted NDA for TransCon PTH (palopegteriparatide) in Adult Patients with Hypoparathyroidism
COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) --Ascendis Pharma, Inc. (Nasdaq: ASND) today announced that the U.S. Food& Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 11, 2023 Category: Drugs & Pharmacology Source Type: news
FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
If approved in the U.S. and EU, marstacimab could become the first once-weekly... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 11, 2023 Category: Drugs & Pharmacology Source Type: news
Ipsen Confirms U.S. FDA Grants Priority Review for New Drug Application for Elafibranor for the Treatment of Rare Cholestatic Liver Disease, PBC
New Drug Application granted priority review with PDUFA date set for June 10, 2024
European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor
Investigational elafibranor is the first novel... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2023 Category: Drugs & Pharmacology Source Type: news
Bridgebio Pharma Announces Submission of New Drug Application to the FDA for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
NDA submission is based on positive results from ATTRibute-CM Phase 3 study, including a highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p<0.0001), on the primary endpoint (a hierarchical analysis prioritizing in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 5, 2023 Category: Drugs & Pharmacology Source Type: news
Vanda Pharmaceuticals Announces that U.S. Food and Drug Administration Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis
WASHINGTON, Dec. 4, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda ' s New Drug Application (NDA) for tradipitant for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 4, 2023 Category: Drugs & Pharmacology Source Type: news
Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia
BOSTON--(BUSINESS WIRE)--Nov. 29, 2023-- Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 29, 2023 Category: Drugs & Pharmacology Source Type: news
Italfarmaco Group Announces New PDUFA Date for Givinostat DMD NDA
MILAN--(BUSINESS WIRE) November 29, 2023 --Italfarmaco Group announced today that the U.S. Food and Drug Administration (FDA) has extended the review process of the New Drug Application (NDA) for Givinostat, the company’s proprietary histone... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 29, 2023 Category: Drugs & Pharmacology Source Type: news
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
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
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
