Drugs

FDA Approves Zepzelca (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer Print this page Madrid and Dublin, June 15th, 2020.- PharmaMar (MSE:PHM) has today announced, along with Jazz Pharmaceuticals plc (Nasdaq: JAZZ), that the U.S. Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic Small

June 15, 2020 Print this page Audience: Health Professional, Pharmacy, Patient ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 12, 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 indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types

FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes Print this page HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 11, 2020 /PRNewswire/ – Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee™ (insulin glargine injection), in

FDA Approves Uplizna (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Print this page GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are

June 11, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 11, 2020 — Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To

Treatment for Dry Eye Disease Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for Eysuvis for Dry Eye Disease Print this page WATERTOWN, Mass.–(BUSINESS WIRE)–May 26, 2020– Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S.

FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta Print this page NEW YORK–(BUSINESS WIRE)– June 11, 2020 — Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile

arimoclomol Treatment for Niemann-Pick Disease, type C Orphazyme Initiates Rolling Submission of New Drug Application for Arimoclomol with US FDA in Niemann-Pick Disease Type C Print this page Copenhagen, Denmark, May 29, 2020 – Orphazyme A/S (ORPHA.CO), a biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announces it has initiated the

Print this page PRINCETON, N.J.–(BUSINESS WIRE) June 10, 2020 Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.1 This application was granted

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 5, 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 approved a supplemental New Drug Application (sNDA) for Recarbrio™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age

June 5, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 05, 2020 — Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA)

June 5, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 05, 2020 — Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI)

FDA Approves Cerianna (fluoroestradiol F18) PET Imaging Agent for Use in Patients with Recurrent or Metastatic Breast Cancer Print this page May 27, 2020 — PETNET Solutions, Inc., a Siemens Healthineers company, and Zionexa USA, a wholly owned subsidiary of Zionexa SAS, have announced that the Food and Drug Administration (FDA) has approved Cerianna™ (fluoroestradiol

FDA Approves Tauvid (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer’s Disease Print this page INDIANAPOLIS, May 28, 2020 /PRNewswire/ — Tauvid, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary

Print this page South San Francisco, CA — May 29, 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 approved Tecentriq ® (atezolizumab) in combination with Avastin ® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have

June 1, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 01, 2020 — Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that the Agency’s

June 1, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy June 1, 2020 — FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. In letters to health care professionals and

FDA Approves Zilxi (minocycline) Topical Foam for the Treatment of Rosacea Print this page BRIDGEWATER, N.J., May 29, 2020 (GLOBE NEWSWIRE) — Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that the U.S. Food and

Print this page June 1, 2020 — AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease. The approval by the US Food and Drug Administration (FDA) was based on

May 28, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy May 28, 2020 — Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP

FDA Approves Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-Menopausal Women Print this page NORTH CHICAGO, Ill., May 29, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved Oriahnn (elagolix,

Print this page NORTHBROOK, Ill., May 27, 2020 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has approved VESIcare LS (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and

FDA Approves Artesunate for Injection for the Treatment of Severe Malaria Print this page FREDERICK, Md., May 27, 2020 /PRNewswire/ — Amivas (US), LLC, specialists in treatments for rare and neglected tropical diseases, including severe malaria, announced today that Artesunate for Injection 110 mg, powder and solvent for solution has received marketing approval by the

Print this page NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of Sirturo (bedaquiline). Sirturo is now indicated for use as part of combination therapy in the treatment of adult

Print this page TARRYTOWN, N.Y. and PARIS, May 26, 2020 /PRNewswire/ – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not

dasiglucagon Treatment for Hypoglycemia Zealand Pharma Announces FDA acceptance of New Drug Application for the Dasiglucagon HypoPal® Rescue Pen for Treatment of Severe Hypoglycemia Print this page Copenhagen, May 22, 2020 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL), a biotechnology company changing lives with innovative peptide-based medicines, today announced that the U.S. Food and Drug Administration

Print this page BOSTON, May 21, 2020 (GLOBE NEWSWIRE) — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has approved Ferriprox® (deferiprone) twice-a-day tablets for the treatment of patients with transfusional iron overload due to thalassemia