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
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
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
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
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
Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS
FOSTER CITY, Calif.--(BUSINESS WIRE) August 21, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has accepted the filing of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 21, 2023 Category: Drugs & Pharmacology Source Type: news
Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults
Cefepime-taniborbactam has also demonstrated in vitro activity against CDC Urgent and Serious Threat Pathogens carbapenem-resistant Enterobacterales, multidrug-resistant Pseudomonas aeruginosa and Extended Spectrum Beta-lactamase-producing... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 15, 2023 Category: Drugs & Pharmacology Source Type: news
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
MALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 9, 2023 Category: Drugs & Pharmacology Source Type: news
Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole
Allschwil, Switzerland, August 04, 2023 -- Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 4, 2023 Category: Drugs & Pharmacology Source Type: news
Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
CONSHOHOCKEN, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced the completion of the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 17, 2023 Category: Drugs & Pharmacology Source Type: news
Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma
FORT LEE, NEW JERSEY, July 17, 2023– Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. And a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility
No issues with clinical efficacy or safety were identified in the CRL
No additional clinical data or trials have been requested
Mumbai, India, July 13, 2023 - Sun Pharma Advanced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 13, 2023 Category: Drugs & Pharmacology Source Type: news
