Drugs

FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency Print this page Plainsboro, NJ, Aug 28, 2020 – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10 mg/ 1.5 mL (6.7 mg/mL) for the replacement of endogenous growth

FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia Print this page PRINCETON, N.J.–(BUSINESS WIRE) September 1, 2020 –Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult

FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair Print this page ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/ — Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug Administration (FDA) has approved Xaracoll  for acute

August 27, 2020 Print this page Audience: Consumers Silver Spring, MD — August 27, 2020 — The U.S. Food and Drug Administration (FDA) is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne Print this page Lainate, Italy – August 27, 2020 – Cassiopea SpA (SIX: SKIN), today announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Notwithstanding acne being the

Print this page THOUSAND OAKS, Calif., Aug. 20, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the Kyprolis (carfilzomib) U.S. prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly

FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis Print this page LEBANON, N.J., Aug. 25, 2020 /PRNewswire/ — Recordati Rare Diseases Inc., today announced the U.S. Food and Drug Administration (FDA) has approved Cystadrops (cysteamine ophthalmic solution) 0.37%. Cystadrops is a new, viscous eye drop solution that depletes corneal cystine crystal

FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis Print this page Basel, August 20, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically

August 20, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy August 20, 2020 — Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry

August 18, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy August 18, 2020 — Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not present

evinacumab Treatment for Homozygous Familial Hypercholesterolemia FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol Print this page TARRYTOWN, N.Y., Aug. 12, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority

Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors Print this page RESEARCH TRIANGLE PARK, N.C. USA, August 11, 2020 – Fennec Pharmaceuticals Inc., a specialty pharmaceutical company,

aducanumab Treatment for Alzheimer’s Disease FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer’s Disease with Priority Review Print this page CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License

FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder Print this page South San Francisco, CA — August 14, 2020 — Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4)

FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy Print this page PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ — NS Pharma, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who

August 12, 2020 Print this page Audience: Consumer, Health Professional Update: August 12, 2020 — FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for

Print this page London, 6 August 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV)

remdesivir Treatment for COVID-19 Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19 Print this page FOSTER CITY, Calif.–(BUSINESS WIRE)–Aug. 10, 2020– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration

FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain Print this page CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug

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

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

FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children Print this page WHIPPANY, N.J.–(BUSINESS WIRE) August 7, 2020 — Bayer announced today that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at

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

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.

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

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,

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

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