Drugs

KENILWORTH, N.J.–(BUSINESS WIRE) October 15, 2020 — Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The
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South San Francisco, CA — October 16, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid
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October 28, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. Use of the defective product
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FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 22, 2020– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication
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Treatment for Schizophrenia, Bipolar Disorder FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, Oct. 9, 2020 /PRNewswire/ – Alkermes plc (Nasdaq: ALKS) today announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA). The
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pacritinib Treatment for Myelofibrosis CTI BioPharma Initiates Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia SEATTLE, Oct. 13, 2020 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has commenced a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (“FDA” or “the Agency”) seeking approval of pacritinib
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News FDA Alerts Drug Safety Communication: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) – Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later October 15, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an
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TARRYTOWN, N.Y., Oct. 14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. “We are
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belumosudil Treatment for Graft Versus Host Disease Kadmon Announces Submission of New Drug Application to the U.S. FDA for Belumosudil in Patients with Chronic Graft-Versus-Host Disease NEW YORK, NY / ACCESSWIRE / September 30, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for belumosudil (KD025), the
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HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This
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PRINCETON, N.J.–(BUSINESS WIRE) October 2, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural
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October 5, 2020 Audience: Consumer, Health Professional, Pharmacy October 05, 2020 — Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified
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PRINCETON, N.J.–(BUSINESS WIRE) October 2, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural
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Print this page BOSTON–(BUSINESS WIRE)–Sep. 25, 2020– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR)
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Print this page KING OF PRUSSIA, PA  – September 28, 2020 – CSL Behring, a global biotherapeutics leader, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Haegarda® (C1 Esterase Inhibitor Subcutaneous [Human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age
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Print this page NEW YORK–(BUSINESS WIRE) September 28, 2020 — Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and
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Treatment for Molybdenum Cofactor Deficiency (MoCD) Type A BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A Print this page SAN FRANCISCO, September 29, 2020 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Origin Biosciences today announced the US Food and
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FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency Print this page DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved
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Treatment for Seizure Clusters Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters Print this page WARREN, N.J., Sept. 25, 2020 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve
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Print this page LAVAL, QC and DEER PARK, Ill., Sept. 25, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc. (NASDAQ: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Alaway® Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye
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idecabtagene vicleucel Treatment for Multiple Myeloma U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) Print this page PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE) September 22, 2020 — Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc.
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Print this page OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE) September 28, 2020 –Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia
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Print this page London UK 25 September 2020 — GlaxoSmithKline plc (GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause. The approval makes
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September 23, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 23, 2020 — Sun Pharmaceutical Industries, Inc. (Sun Pharma), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of Riomet ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason
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pegcetacoplan Treatment for Paroxysmal Nocturnal Hemoglobinuria Apellis Announces Submission of Pegcetacoplan Marketing Applications to FDA and EMA for Patients with PNH Print this page WALTHAM, Mass., Sept. 15, 2020 (GLOBE NEWSWIRE) – Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company has submitted a New Drug Application (NDA) to the
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September 24, 2020 Print this page Audience: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of news reports of teenagers ending up in emergency rooms
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loncastuximab tesirine Treatment for Diffuse Large B-cell Lymphoma ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma Print this page LAUSANNE, Switzerland–(BUSINESS WIRE)– September 24, 2020 — ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company
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