Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection.
U.S. FDA: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ).
TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.
MERCK: LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer
LYNPARZA Reduced the Risk of Disease Progression or Death by 47% Compared to Placebo in Patients Whose Disease Had Not Progressed On at Least 16 Weeks of a First-Line Platinum-Based Chemotherapy Regimen. Only PARP Inhibitor Approved in Germline BRCA-mutated Advanced Pancreatic Cancer
U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
U.S. FDA: FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.
DOVA PHARMACEUTICALS, INC: FDA Grants Avatrombopag Orphan Drug Designation for the Treatment of Chemotherapy-induced Thrombocytopenia
Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™) has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of Chemotherapy-Induced Thrombocytopenia (CIT).
GRUNETHAL GROUP: Averitas Pharma Announces FDA Acceptance of sNDA Filing for QUTENZA® (capsaicin) 8% Patch for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
PDUFA date set for July 19, 2020. If approved, QUTENZA would be the first topical treatment with a TRPV1 agonist indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
BAUSCH HEALTH: FDA Approves Ortho Dermatologics' ARAZLO™ (Tazarotene) Lotion, 0.045%, For Acne Vulgaris
First Tazarotene Acne Treatment Approved in Lotion Formulation
U.S. FDA: First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response
The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.
AMGEN: FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)
Amgen's Fourth FDA Approval From Biosimilars Portfolio
LUMOSA THERAPEUTICS: Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the US
LT1001 (brand name Naldebain®) is a prodrug of nalbuphine, an abuse-free analgesic that has been marketed worldwide for decades.
SK LIFE SCIENCE, INC.: Announces FDA Acceptance of IND Application for Anti-Epileptic Drug Candidate SKL24741
Acceptance of the IND application will allow the company to begin Phase I clinical trials for SKL24741 in 2020
U.S. FDA: FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection
The U.S. Food and Drug Administration approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).
FDA Approves XCOPRI® (cenobamate tablets), an Anti-Epileptic Drug (AED) from SK Biopharmaceuticals, Co., Ltd., and U.S. Subsidiary SK Life Science, Inc.
XCOPRI is approved for the treatment of partial-onset seizures in adult patients
SURMODICS: The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices