Print this page LAVAL, Quebec, April 29, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Jublia® (efinaconazole) topical solution, 10%, a
Drugs
brincidofovir Treatment for Smallpox Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox Print this page DURHAM, N.C., April 28, 2020 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the Company
Print this page London UK — 29 April 2020 – Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend
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
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
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.
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
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
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
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
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)
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
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,
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
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
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,
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
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).
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
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.
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
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
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
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
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
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
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
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.