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Tag Archives: FDA

Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn’s Disease

Monday, July 22nd 2019 at 5:00am UTC Vedolizumab subcutaneous is currently under review for approval for ulcerative colitis with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) OSAKA, Japan–(BUSINESS WIRE)– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial …

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Dr. Reddy’s announces the launch of over-the-counter, store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) in the U.S. Market

Friday, July 19th 2019 at 6:29am UTC HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)– Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, …

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Dr. Reddy’s announces the launch of over-the-counter, store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) in the U.S. Market

Friday, July 19th 2019 at 6:29am UTC HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)– Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, …

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Medicare Releases Final Local Coverage Determination Providing Coverage of Optune® for Newly Diagnosed Glioblastoma

Thursday, July 18th 2019 at 10:57am UTC ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) today announced the Medicare durable medical equipment (DME) Medicare Administrative Contractors (MACs) have released a final local coverage determination (LCD) providing coverage of Optune for Medicare beneficiaries with newly diagnosed glioblastoma (GBM) effective September 1, 2019. …

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LifeMax Receives Rare Pediatric Disease Designation for LM-030 for the Treatment of Netherton Syndrome

Thursday, July 18th 2019 at 11:00am UTC PALO ALTO, Calif.–(BUSINESS WIRE)– LifeMax Laboratories, Inc. (“LifeMax”), a private company focused on treating rare diseases with few or no therapeutic options, today announced that the Food & Drug Administration (FDA) granted rare pediatric disease designation to LM-030, an investigational therapy licensed from …

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Pear Therapeutics Announces FDA Submission for Somryst™, a Prescription Digital Therapeutic for the Treatment of Adults with Chronic Insomnia and Depression

Thursday, July 18th 2019 at 12:35pm UTC More than 30 million U.S. adults have chronic insomnia, at significant cost to the U.S. healthcare system Cognitive Behavioral Therapy for insomnia (CBTi) is the guideline recommended first-line treatment for people with chronic insomnia The investigational product is a prescription digital therapeutic (PDT) …

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Bioasis Announces Stock Option Grants

Wednesday, July 17th 2019 at 8:05pm UTC GUILFORD, Conn.–(BUSINESS WIRE)– Bioasis Technologies Inc. (OTCQB:BIOAF; TSX.V:BTI), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 ™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high …

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Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-ANG3

Tuesday, July 16th 2019 at 8:00pm UTC PASADENA, Calif.–(BUSINESS WIRE)– Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ARO-ANG3 for the treatment of homozygous familial hypercholesterolemia (HoFH). ARO-ANG3 is a subcutaneously administered RNA interference (RNAi)-based investigational medicine …

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NorthStar Medical Radioisotopes Announces Construction Completion of Beloit, Wisconsin Processing Facility for Expanded Domestic Production of Medically Important Molybdenum-99 (Mo-99)

Tuesday, July 16th 2019 at 12:30pm UTC ? Facility part of staged, dual production pathway plan to expand Mo-99 production and efficiency in parallel with RadioGenix® System enhancements ? ? RadioGenix System customers provided with reliable Mo-99 supply throughout eight months since commercial launch, helping mitigate concurrent industry disruptions ? …

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Seattle Genetics and Astellas Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

Tuesday, July 16th 2019 at 12:00pm UTC -Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology- BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)– Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced …

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