Drugs

New study shows omega-3 benefits heart health and decreases risk for heart attack. Cardiovascular disease is the leading cause of death in the world and is the cause of death in approximately 17.9 million people annually. Poor health conditions such as high blood pressure, high cholesterol, obesity, and smoking lead to cardiovascular disease. There are

Researchers in China evaluated the future cardiovascular risk of high blood pressure in young people. High blood pressure is a well-recognized risk factor for cardiovascular problems such as heart attack or stroke in later life. Reducing raised blood pressure through healthy lifestyle improvements (such as increasing exercise, losing weight or stopping smoking) and antihypertensive medication

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

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

In a large multi-year study, investigators study the benefits of eating nuts in preventing gradual weight gain.   Despite being high in calories, just a half serving of nuts per day (14 gm or ½ oz) is associated with a lower risk of weight gain and obesity, just one of the benefits of eating nuts,

Researchers characterize the clinical, immunological, and virologic aspects of patients who re-test positive for coronavirus.           The continuing COVID-19 pandemic remains a burden on social, economic, and healthcare systems. As more becomes known about the respiratory syndrome, interventions and preventative measures are being implemented to slow its spread. There is however, a gap in knowledge

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

News FDA Alerts Drug Safety Communication: Benzodiazepine Drug Class – Boxed Warning Updated to Improve Safe Use September 23, 2020 Print this page Audience: Patient, Health Professional, Pharmacy ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This

A new research study shows that a safe UV disinfection system effectively kills coronavirus. Recent studies have reported that SARS-CoV-2 can survive on surfaces for several days and that hospitals may be a potential source of transmission due to contaminated surfaces. With an aim to slow the spread of COVID-19, a recent study investigated the

umbralisib Treatment for Marginal Zone Lymphoma; Follicular lymphoma TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma Print this page NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) – TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted

News FDA Alerts FDA Alerts of Perrigo’s Voluntary Albuterol Inhaler Recall September 21, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 21, 2020 — The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions

trilaciclib Treatment for Small Cell Lung Cancer G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer Print this page RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) – G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New

vosoritide Treatment for Achondroplasia BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia Print this page SAN RAFAEL, Calif., Aug. 20, 2020 /PRNewswire/ – BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for

September 17, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy September 17, 2020 — Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots

veverimer Treatment for Metabolic Acidosis in Chronic Kidney Disease Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD Print this page SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Aug. 24, 2020– Tricida, Inc. (Nasdaq:

casimersen Treatment for Duchenne Muscular Dystrophy Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45 Print this page CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the

News New Drug Applications Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C arimoclomol Treatment for Niemann-Pick Disease, type C Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C Print this page Copenhagen, Denmark, September 16, 2020 –

tepotinib Treatment for Non-Small Cell Lung Cancer FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations Print this page ROCKLAND, Mass., Aug. 25, 2020 /PRNewswire/ – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug

FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent Print this page Houston, TX and St. Louis, MO, Sept. 08, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA).  Detectnet

terlipressin Treatment for Hepatorenal Syndrome Type 1 Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1) Print this page DUBLIN, Sept. 14, 2020 /PRNewswire/ – Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued

Print this page NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that its New Drug Application (NDA) for Epsolay® (benzoyl peroxide), an investigational proprietary topical cream for the treatment of

Print this page London UK 9 September 2020 — GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to