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

Lupin gets USFDA nod for Bromfenac Ophthalmic Solution
Pharma major Lupin on Wednesday said it has received approval from the US health regulator to market its generic Bromfenac Ophthalmic Solution used to treat post-operative inflammation in patients who have undergone cataract surgery. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Bromfenac Ophthalmic Solution 0.09 per cent, Lupin said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 16, 2023 Category: Pharmaceuticals 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 shares plunge 85% on FDA rejection; workforce cut by more than half
The Food and Drug Administration rejected Galera's new drug application for an experimental therapy designed to treat a side effect of a cancer treatment. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 10, 2023 Category: Pharmaceuticals Authors: John George 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

Europe Approves Empagliflozin for Chronic Kidney Disease Europe Approves Empagliflozin for Chronic Kidney Disease
The SGLT2 inhibitor empagliflozin (Jardiance) was approved by European regulators for treating adults with chronic kidney disease. The FDA is reviewing a new drug application for this indication.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - July 27, 2023 Category: Internal Medicine Tags: Diabetes & Endocrinology News Alert 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 Approves Veklury (remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis
FOSTER CITY, Calif.--(BUSINESS WIRE) July 14, 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® (remdesivir)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 14, 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

FDA Approves Medicines360 ’s Supplemental New Drug Application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg as Treatment of Heavy Menstrual Bleeding
SAN FRANCISCO, CA -- July 10, 2023 -- Medicines360, a global nonprofit organization with a mission to catalyze equitable access to quality medicines for women, announced today that the U.S. Food and Drug Administration (FDA) has approved its... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 10, 2023 Category: Drugs & Pharmacology Source Type: news

Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application
TOKYO, July 6, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, " Astellas " ) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company ' s Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 6, 2023 Category: Drugs & Pharmacology Source Type: news

Amneal Receives U.S. FDA Complete Response Letter for IPX203
BRIDGEWATER, N.J.--(BUSINESS WIRE) July 03, 2023 --Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the“Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 3, 2023 Category: Drugs & Pharmacology Source Type: news

Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), initiated a rolling submission of a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 30, 2023 Category: Drugs & Pharmacology Source Type: news