FDA Grants Expanded Approval to Wilate as the First VWF Concentrate for Prophylaxis in All Types of VWD
Paramus, NJ 07/12/2023 Octapharma USA announced the expansion of the U.S. Food and Drug Administration (FDA) approval for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 7, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Avzivi (bevacizumab-tnjn), a Biosimilar to Avastin
GUANGZHOU, China, Dec. 7, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 7, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Fabhalta (iptacopan) for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Basel, December 6, 2023— Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)1.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 6, 2023 Category: Drugs & Pharmacology Source Type: news
Jaypirca (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor
The first and only non-covalent (reversible) BTK inhibitor, Jaypirca has been shown to extend the benefit of BTK inhibition
In the BRUIN Phase 1/2 trial, adult patients with CLL/SLL who have received at least two lines of therapy, including a BTK... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ogsiveo (nirogacestat) for Adults with Desmoid Tumors
STAMFORD, Conn., Nov. 27, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ryzneuta (efbemalenograstim alfa) for Chemotherapy-Induced Neutropenia
November 22, 2023, New Jersey– Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., and Acrotech Biopharma (Acrotech), a New Jersey-based... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 22, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Truqap (capivasertib) plus Faslodex for Patients with Advanced HR-Positive Breast Cancer
17 November 2023 -- AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Merck ’s Keytruda (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Approval marks seventh gastrointestinal cancer indication for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2023 Category: Drugs & Pharmacology Source Type: news
Pfizer and Astellas' Xtandi Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
TOKYO and NEW YORK, Nov. 16, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, " Astellas " ) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Augtyro (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves DefenCath (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients
Berkeley Heights, NJ– November 15, 2023– CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 15, 2023 Category: Drugs & Pharmacology Source Type: news
Pacira Announces FDA Approval of Expanded Exparel Label to Include Two Additional Nerve Block Indications
Exparel is the only FDA-approved single-dose regional analgesic to safely demonstrate four days of superiority versus bupivacaine in two clinical studies—
New indications for use as an adductor canal block and sciatic nerve block in the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus
Saint-Herblain (France), November 10, 2023– Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved Ixchiq®, Valneva’s single-dose,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Adzynma (ADAMTS13, recombinant-krhn) Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
OSAKA, Japan& CAMBRIDGE, Mass., November 09, 2023--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Adzynma (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Fruzaqla (fruquintinib) for Previously Treated Metastatic Colorectal Cancer
Fruzaqla is the First Targeted Therapy Approved for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in More Than a Decade
Fruzaqla Plus Best Supportive Care Demonstrated Significant Improvements in Overall Survival, with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 8, 2023 Category: Drugs & Pharmacology Source Type: news
