The U.S. Food and Drug Administration today announced that, on behalf of the agency, the U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held under insanitary conditions in which they were exposed to widespread rodent, insect and live animal infestation. The seizure occurred Nov. 7 and 8 at J […]Continue Reading ...
Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide […]Continue Reading ...
Treatment for Major Depressive Disorder Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder DUBLIN, Nov. 1, 2018 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the […]Continue Reading ...
RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene […]Continue Reading ...
Home News FDA Alerts FDA Alerts Patients and Health Care Professionals that Some EpiPen Auto-Injectors May Not Readily Slide Out of Carrier Tube November 2, 2018 Audience: Consumer, Health Professional, Pharmacy [11/2/2018] FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and […]Continue Reading ...
FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira Holzkirchen, Germany, October 31, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis […]Continue Reading ...
Immusoft Corporation, a Seattle-Wash.-based cell therapy company, announced today that the U.S. Food and Drug Administration (FDA) has granted it Rare Pediatric Disease Designation (RPDD) for Iduronicrin genleukocel-T, Immusoft’s Sleeping Beauty transposon-engineered autologous plasmablasts for the expression and delivery of alpha-L-iduronidase (IDUA) to treat Mucopolysaccharidosis type I (MPS I). “This important designation from the FDA […]Continue Reading ...
Treatment for Pain Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome October 11, 2018 — Trevena, Inc. (NASDAQ: TRVN), today announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. At the meeting, the Advisory Committee voted 8 […]Continue Reading ...
Treatment for Pain Trevena Receives Complete Response Letter for Oliceridine from FDA November 2, 2018 — Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we […]Continue Reading ...
Home News New Drugs FDA Approves Yupelri FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD) November 09, 2018 — Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist (LAMA), which is […]Continue Reading ...
FRIDAY, Nov. 2, 2018 — Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia. The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. The tiny […]Continue Reading ...
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving […]Continue Reading ...
FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause BOCA RATON, Fla.–(BUSINESS WIRE)–Oct. 29, 2018– TherapeuticsMD, Inc, an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, the first […]Continue Reading ...
When 12-year-old Lizneidy Serratos was airlifted to the Bay Area in early August, her heart was pumping so weakly that she could not walk or eat. Even the flavor of toothpaste made her nauseated, her pediatric cardiologist, Christopher Almond, MD, told me. At home in Reno, Lizneidy had just been diagnosed with a severe form […]Continue Reading ...
Home News New Drug Applications FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys Treatment for Nausea/Vomiting — Postoperative FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys Cambridge, UK and Indianapolis, US – 8 October 2018: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products […]Continue Reading ...
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