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
admin
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
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 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).
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.
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
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
My two greatest fears before starting my pediatric rotation were finding common ground with a critically ill child and looking incompetent. The second fear seemed easy enough to conquer if I studied the material prior to my clinical days. The first one, however, would be more difficult and out of my control. How would I
Treatment for Pulmonary Arterial Hypertension (PAH) Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension Print this page RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) — Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization
FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes Print this page SAN DIEGO – April 27, 2020 – Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Ongentys (opicapone) 25 mg and 50 mg capsules as an
April 24, 2020 Print this page Audience: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional ISSUE: FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials
Print this page London, UK 23 April 2020 — GlaxoSmithKline plc today announced data from an updated analysis of the GARNET trial, which demonstrated that dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based
Reviewed by Emily Henderson, B.Sc.Apr 28 2020 Researchers at the Wyss Institute at Harvard University, in collaboration with healthcare, research, and industrial partners, have designed a new, fully injection-molded nasopharyngeal swab that can be manufactured quickly and inexpensively at high volume to help address the nationwide and international shortage of swabs for COVID-19 testing and
Print this page Paris and Tarrytown, N.Y. April 27, 2020 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with “severe” or “critical” respiratory illness caused by COVID-19. Following
Reviewed by Emily Henderson, B.Sc.Apr 28 2020 By leveraging the basics of artificial intelligence technology now used to predict risk for suicide or other mental health issues, researchers developed an AI system that analyzes linguistic patterns to predict a youth’s risk for committing acts of school violence. Study data published in the International Journal of
The FDA and WHO have both made statements that smoking may increase both the risk of COVID-19 as well as severity. This assertion of risk, however, is rooted in expectation rather than data. Meanwhile, the available studies show an unanticipated protective effect on COVID-19 incidence in smokers and a less clear association with disease severity.