FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc. ’s generics of Prograf (tacrolimus) oral capsules  
Based on new data, the U.S. Food and Drug Administration is changing the therapeutic equivalence rating for tacrolimus oral capsule products manufactured by Accord Healthcare Inc. under abbreviated new drug application 091195. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 18, 2023 Category: Drugs & Pharmacology Source Type: news

RedHill Announces FDA sNDA Approval for Simplified Dosage Regimen for Talicia
FDA approves supplemental new drug application (sNDA) for Talicia, changing dosing to a simplified three times daily (TID) regimen, which may support increased patient adherence and treatment outcomes Talicia is the leading branded first-line... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 18, 2023 Category: Drugs & Pharmacology Source Type: news

Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis
CONSHOHOCKEN, Pa., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 13, 2023 Category: Drugs & Pharmacology Source Type: news

Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants
Prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their 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 - September 12, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
Overall response rate (ORR) greater than 50% across three assessment criteria Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment FDA filing decision expected by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 11, 2023 Category: Drugs & Pharmacology Source Type: news

Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD
PDUFA Target Action Date of June 26, 2024 Ensifentrine, if approved, is expected to be the first novel mechanism available for the maintenance treatment of COPD in more than a decade LONDON and RALEIGH, N.C., Sept. 11, 2023 (GLOBE NEWSWIRE) --... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 11, 2023 Category: Drugs & Pharmacology Source Type: news

Madrigal taps former Sanofi North America president as new CEO after completing key new drug application
The company's new CEO formerly led a staff of about 10,000 at Sanofi North America. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 11, 2023 Category: Pharmaceuticals Authors: John George Source Type: news

Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) Date
FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for treatment of seizure clusters in patients between two and five years of age Prescription Drug User Fee Act (PDUFA) target goal date set for April 28, 2024 WARREN, N.J., Sept.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 11, 2023 Category: Drugs & Pharmacology Source Type: news

Natco Pharma, others sued in US for generic cancer drug
The company believes this matter is without merit, Natco Pharma said in a statement. Breckenridge is the abbreviated new drug application (ANDA) holder and distribution partner for the generic product in the US, it added. Natco Pharma shares were trading 3.13 per cent down at Rs 885.00 apiece on the BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2023 Category: Pharmaceuticals Source Type: news

X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome
BOSTON, Sept. 05, 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 the submission of a New Drug Application (NDA) to the United... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 5, 2023 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Application for Genentech ’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition
South San Francisco, CA -- September 4, 2023 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 4, 2023 Category: Drugs & Pharmacology Source Type: news

FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
FOSTER CITY, Calif.--(BUSINESS WIRE) August 24, 2023 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2023 Category: Drugs & Pharmacology Source Type: news

Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS
FOSTER CITY, Calif.--(BUSINESS WIRE) August 22, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has assigned a standard review and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 22, 2023 Category: Drugs & Pharmacology Source Type: news

Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application for Vonoprazan
Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf life Submission of six-month stability data satisfies Phathom ' s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 21, 2023 Category: Drugs & Pharmacology Source Type: news