Month: April 2020

Got Food Allergies? Add Milk To The Worries For Your Meal by Carmen Heredia Rodriguez: [email protected], @caheredia21, Kaiser Health News (KHN) Since her son Matt was an infant, Lynda Mitchell knew he had a milk allergy. She controlled the symptoms by switching his baby formula. But when he was 1, Halloween proved horrifying. While trick-or-treating in
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Treatment for Breast cancer FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer Print this page South San Francisco, CA — February 24, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration
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Treatment for Dravet Syndrome Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome Print this page EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for
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tanezumab Treatment for Osteoarthritis U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis Print this page Monday, March 2, 2020 – Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a
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tirbanibulin Treatment for Actinic Keratosis Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis Print this page BUFFALO, N.Y., March 09, 2020 (GLOBE NEWSWIRE) – Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, announced today
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ponesimod Treatment for Multiple Sclerosis Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis Print this page TITUSVILLE, NEW JERSEY, March 18, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S.
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tivozanib Treatment for Renal Cell Carcinoma AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma Print this page CAMBRIDGE, Mass.–(BUSINESS WIRE)–Mar. 31, 2020– AVEO Oncology (NASDAQ: AVEO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
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idecabtagene vicleucel Treatment for Multiple Myeloma Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA Print this page March 31, 2020 — PRINCETON, NJ. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the
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naxitamab Treatment for Neuroblastoma Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA Print this page NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) – Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that
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lumasiran Treatment for Primary Hyperoxaluria Type 1 (PH1) Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 Print this page CAMBRIDGE, Mass.–(BUSINESS WIRE)– April 07, 2020 — Alnylam Pharmaceuticals,
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Print this page April 8, 2020 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior
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FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas Print this page 13 April 2020 — AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved the kinase inhibitor Koselugo
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FDA Approves Jelmyto (mitomycin) for Treatment of Low-Grade Upper Tract Urothelial Cancer Print this page PRINCETON, N.J.–(BUSINESS WIRE)–Apr. 15, 2020– UroGen Pharma Ltd. (Nasdaq: URGN) today announced the U.S. Food and Drug Administration (FDA) granted expedited approval for Jelmyto (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer
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FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer Print this page BOTHELL, Wash.–(BUSINESS WIRE) April 17, 2020 — Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable
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FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma Print this page WILMINGTON, Del.–(BUSINESS WIRE)–Apr. 17, 2020– Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated,
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Print this page NORTH CHICAGO, Ill., April 21, 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the use of Imbruvica® (ibrutinib) in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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FDA Approves Emerphed (ephedrine sulfate) Ready-to-Use Injection for Hypotension During Anesthesia Print this page Lincolnshire, Ill., April 21, 2020 — Nexus Pharmaceuticals announced today it has received U.S. Food and Drug Administration (FDA) approval for its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial.
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FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer Print this page Morris Plains, N.J., April 22, 2020 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy™ (sacituzumab govitecan-hziy) for the treatment
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Print this page PARIS – April 24, 2020 – The U.S. Food and Drug Administration (FDA) has approved a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older. “Meningococcal meningitis remains a major global health challenge
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News FDA Alerts Ivermectin Intended for Animals: FDA Warns – Do Not Use in Humans as a Treatment for COVID-19 April 10, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy, Veterinary ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be
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April 13, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy FDA Publish Date:April 13, 2020 Company Announcement Date: January 25, 2018 — Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to
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April 13, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy FDA Publish Date:April 13, 2020 Company Announcement Date:January 18, 2018 — Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna
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April 13, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy FDA Publish Date:April 13, 2020 Company Announcement Date:January 28, 2018 — Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have
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April 15, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy April 15, 2020 — Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned
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April 16, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy April 16, 2020 — Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.
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April 20, 2020 Print this page Audience: Health Professional, Pharmacy April 20, 2020 — Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were
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April 20, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy April 20, 2020 — Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a
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April 23, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy April 23, 2020 — The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). This action is a continuation of
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