Drugs

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain SAN DIEGO, May 13, 2021 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food
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Treatment for Pulmonary Arterial Hypertension (PAH) Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension MORRISVILLE, N.C., May 10, 2021 (GLOBE NEWSWIRE) – Liquidia Corporation (NASDAQ: LQDA) announced today that on May 7, 2021, it resubmitted its New Drug Application (NDA) for LIQ861 for the treatment of pulmonary arterial hypertension (PAH). The U.S.
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KENILWORTH, N.J.–(BUSINESS WIRE) May 5, 2021– 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 Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive
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News FDA Alerts Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil May 11, 2021 Audience: Consumers May 11, 2021 — Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain
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BASKING RIDGE, N.J. and SHIRLEY, N.Y., May 6, 2021 /PRNewswire/ — Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a single 1000 mg dose option of Injectafer® (ferric carboxymaltose injection), an iron replacement product, for the treatment of iron deficiency anemia (IDA) in adult
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May 10, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy May 10, 2021 — Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts
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May 4, 2021 Audience: Health Professional, Pharmacy May 04, 2021 — Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate. Hospira’s assessment of
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Treatment for Macular Edema, Uveitis Clearside Biomedical Announces Resubmission of New Drug Application for Xipere for Treatment of Macular Edema Associated with Uveitis ALPHARETTA, Ga., May 03, 2021 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back
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30 April 2021 Approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years In DAPA-CKD Phase III trial, Farxiga demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death  AstraZeneca’s Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2)
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May 1, 2021 Approval is based on demonstrated reduction in liver iron concentration Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia – BOSTON, May 1, 2021 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today
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FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose LONDON, April 30, 2021 /PRNewswire/ — Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) for the emergency treatment of known or suspected opioid overdose,
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April 30, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy April 30, 2021 — Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled
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Treatment for Major Depressive Disorder Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder NEW YORK, April 26, 2021 (GLOBE NEWSWIRE) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and
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bardoxolone Treatment for Alport Syndrome Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome PLANO, Texas, April 26, 2021 (GLOBE NEWSWIRE) — Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that the U.S.
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mobocertinib Treatment for Non-Small Cell Lung Cancer Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE) April 27, 2021– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and
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FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma LAUSANNE, Switzerland–(BUSINESS WIRE) APRIL 23, 2021 — ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after
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FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer London UK 22 April 2021 – GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics License Application. Jemperli is indicated for the treatment of adult
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pacritinib Treatment for Myelofibrosis CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia SEATTLE, March 31, 2021 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”) seeking approval of pacritinib as
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ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ — ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the
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PRINCETON, N.J.–(BUSINESS WIRE)– April 16, 2021 Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population1 U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless
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April 16, 2021 Audience: Consumers April 16, 2021 — Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination. The issue was
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FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 13, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1
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FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control 15 April 2021, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel
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tisotumab vedotin Treatment for Cervical Cancer Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has
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South San Francisco, CA — April 12, 2021 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only
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FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The
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