Drugs

August 5, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy August 05, 2020 — Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products
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FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older Print this page South San Francisco, CA — August 7, 2020 — Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi (risdiplam) for treatment of
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Print this page TITUSVILLE, N.J. – (August 3, 2020) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major
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FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex Print this page CARLSBAD, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, Inc., today announced the U.S.
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FDA Approves Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma Print this page London UK 05 August 2020 — GlaxoSmithKline announced the US Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received
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Print this page South San Francisco, CA — July 30, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety
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idecabtagene vicleucel Treatment for Multiple Myeloma Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma Print this page PRINCETON, N.J., & CAMBRIDGE, Mass.– July 29, 2020 — (BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and bluebird bio,
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July 31, 2020 Print this page Audience: Consumer, Health Professional Update July 31, 2020: FDA continues to find issues with certain hand sanitizer products. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The agency urges consumers not to
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FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Print this page PLANEGG/MUNICH, Germany – August 1, 2020 and WILMINGTON, Del. – July 31, 2020 MorphoSys AG NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi
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arimoclomol Treatment for Niemann-Pick Disease, type C Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C Print this page Copenhagen, Denmark, July 20, 2020 – Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response in order to develop and commercialize novel therapeutics for the
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July 30, 2020 Print this page Audience: Consumer, Health Professional ISSUE: FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. The agency is aware of people
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voclosporin Treatment for Lupus Nephritis Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis Print this page VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE) July 21, 2020 — Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”),
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Treatment for Congestive Heart Failure scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission Print this page BURLINGTON, Mass.–(BUSINESS WIRE)–Jul. 27, 2020– scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today
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FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the Maintenance Treatment of COPD Print this page 24 July 2020 — AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the US Food and Drug Administration (FDA) was based on
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FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice Print this page HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE) July 27, 2020 –Dr. Reddy’s Laboratories Ltd. today announced approval of Xeglyze (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration. The approval triggers the contractual pre-commercialization milestone of $20 million
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July 27, 2020 Print this page Audience: Consumers, Health Care Professionals July 27, 2020 — The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and
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FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma Print this page SANTA MONICA, Calif.–(BUSINESS WIRE)–Jul. 24, 2020– Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only
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FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis Print this page COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / — MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has
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July 22, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy July 22, 2020 — Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility
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News FDA Alerts Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder – FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing July 23, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder
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FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy Print this page DUBLIN, July 22, 2020 /PRNewswire/ – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of
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FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis Print this page COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / — MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration
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Print this page AACHEN, Germany and MORRISTOWN, N.J., July 21, 2020 /PRNewswire/ — Grünenthal announced today that its U.S. subsidiary Averitas Pharma, Inc. received U.S. Food and Drug Administration (FDA) approval for Qutenza (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.[2] Qutenza is
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terlipressin Treatment for Hepatorenal Syndrome Type 1 Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1) Print this page DUBLIN, July 15, 2020 /PRNewswire/ – Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S.
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vericiguat Treatment for Heart Failure with Reduced Ejection Fraction (HFrEF) FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat Print this page KENILWORTH, N.J.–(BUSINESS WIRE) July 16, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted
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Treatment for Molluscum Contagiosum Verrica Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum Print this page WEST CHESTER, Pa., July 14, 2020 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced
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Print this page HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.[1],[2] Tremfya is the first treatment
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