Merck Provides U.S. Regulatory Update on Gefapixant
RAHWAY, N.J.--(BUSINESS WIRE) December 20, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Groundbreaking iDose ® TR for Glaucoma Treatment Following Successful Clinical Trials Conducted by Parkhurst NuVision and Glaukos
Parkhurst NuVision, a leading ophthalmic clinic and Glaukos have reached a significant milestone with the U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for iDose® TR (travoprost intracameral implant) 75 mcg. This pioneering prostaglandin analog... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - December 19, 2023 Category: Pharmaceuticals Tags: TRI FDA Source Type: news
U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer
WALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 18, 2023 Category: Drugs & Pharmacology Source Type: news
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
NDA is supported by data evaluating seladelpar efficacy and safety in over 500 patients
Seladelpar is the first New Drug Application from CymaBay in its ongoing mission to help people living with PBC
NEWARK, Calif., Dec. 15, 2023 -- (Healthcare Sales... Biopharmaceuticals, FDA CymaBay Therapeutics, seladelpar, primary biliary cholangitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 15, 2023 Category: Pharmaceuticals Source Type: news
MAPS Celebrates Submission of New Drug Application to FDA for MDMA-Assisted Therapy for PTSD
MAPS incubated the program that generated the first NDA submission for any psychedelic-assisted therapy • Submission represents 30-plus years of philanthropy-driven clinical research into potential use of MDMA-assisted therapy for PTSD • If accepted for review by the FDA, the application could be…#maps #nda #submission #mdma #fda #sanjose #newdrugapplication #pbc #timferriss #saiseifoundation (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2023 Category: Consumer Health News Source Type: news
Company Seeks FDA Approval for MDMA as Treatment for PTSD
WEDNESDAY, Dec. 13, 2023 -- A California company is asking the U.S. Food and Drug Administration to consider approving MDMA (midomafetamine capsules) as a treatment for posttraumatic stress disorder (PTSD).When announcing the new drug application... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 13, 2023 Category: Pharmaceuticals Source Type: news
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
Generic Drugs Program Activities Report - FY 2023 Monthly Performance
This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications. Data includes approvals, applications received, complete responses, and more. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 12, 2023 Category: Drugs & Pharmacology Authors: FDA 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
Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE
The application is based on phase 3 results from the ReOpen clinical trial program showing XHANCE significantly reduced symptoms and sinus opacification in participants with chronic rhinosinusitis If approved, XHANCE is expected to be the first and only drug indicated for the treatment of chronic…#reopen #xhance #yardley #optn #fda #pdufa #ramymahmoud #mph #eds #item1ariskfactors (Source: Reuters: Health)
Source: Reuters: Health - December 6, 2023 Category: Consumer Health News Source Type: news
Lupin gets USFDA nod for generic smoking cessation treatment tablets
Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Varenicline tablets indicated for use as an aid to smoking cessation treatment. The approval by the US FDA is for the abbreviated new drug application for Varenicline tablets of strengths 0.5 mg and 1 mg, Lupin said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 6, 2023 Category: Pharmaceuticals 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
