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
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
