FDA Approves Exblifep (cefepime/enmetazobactam) for the Treatment of Complicated Urinary Tract Infections
SAINT-LOUIS, France& WEILL AM RHEIN, Germany February 27, 2024 -- Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 27, 2024 Category: Drugs & Pharmacology Source Type: news
Johnson & Johnson Announces Expansion of Imbruvica (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications
HORSHAM, PA. February 26, 2024– Johnson& Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Expanded Indication for Gilead ’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-Existing Resistance
FOSTER CITY, Calif.--(BUSINESS WIRE) February 26, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira
REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 25, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to to Humira
REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 25, 2024 Category: Drugs & Pharmacology Source Type: news
Tecvayli (teclistamab-cqyv) Biweekly Dosing Approved by the U.S. FDA for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tecvayli (teclistamab-cqyv) for a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 20, 2024 Category: Drugs & Pharmacology Source Type: news
Tagrisso With the Addition of Chemotherapy Approved in the US for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer
19 February 2024 -- AstraZeneca’s Tagrisso has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The approval... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 19, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Amtagvi (lifileucel) for the Treatment of Advanced Melanoma
SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 19, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies
South San Francisco, CA -- February 16, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 16, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Grants Traditional Approval to Tepmetko (tepotinib) for Metastatic Non-Small Cell Lung Cancer
On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 15, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite
February 14, 2024 -- The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. " This approval provides patients with the first-ever treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 14, 2024 Category: Drugs & Pharmacology Source Type: news
Ipsen ’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA
PARIS, FRANCE, 13 February 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 13, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis
OSAKA, Japan and CAMBRIDGE, Massachusetts, February 12, 2024– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 12, 2024 Category: Drugs & Pharmacology Source Type: news
Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta CAR T-cell Therapy
New Median Turnaround Time from Leukapheresis to Product Release in U.S. Anticipated to be Reduced from 16 Days to 14 Days
Continues to Support Kite’s Industry-Leading Overall Turnaround Time and Reliability
Time to Treatment is a Critical... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 30, 2024 Category: Drugs & Pharmacology Source Type: news
Takeda ’s Gammagard Liquid Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
New Indication Delivers on Takeda’s Commitment to Expanding its Broad and Diverse Immunoglobulin (IG) Portfolio to Meet the Needs of People Living with CIDP
Approval Supported by Phase 3 ADVANCE-CIDP Open-label Study Data Demonstrating... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 29, 2024 Category: Drugs & Pharmacology Source Type: news
