Drugs

DUBLIN, Aug. 12, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.1 The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following

News FDA Alerts Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine August 11, 2021 Audience: Consumer August 11, 2021 — Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to

FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors KENILWORTH, N.J.–(BUSINESS WIRE) August 13, 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 Welireg, an oral hypoxia-inducible factor-2 alpha

roxadustat Treatment for Anemia Associated with Chronic Renal Failure FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) – FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat

August 10, 2021 Audience: Health Professional, Pharmacy  August 10, 2021 — SterRx, LLC today announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous

Treatment for Neutropenia Associated with Chemotherapy Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim) HENDERSON, Nev.–(BUSINESS WIRE)–Aug. 6, 2021– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the

Treatment for Measles Prophylaxis, Mumps Prophylaxis, Rubella Prophylaxis GSK Files for Licensure of Priorix MMR Vaccine in the US August 2, 2021 — GSK today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Priorix (Measles, Mumps, and Rubella Virus Vaccine, Live) and is seeking approval

FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease PARIS – August 6, 2021 – The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder that impairs a person’s ability to move

August 6, 2021 Audience: Health Professional, Pharmacy  KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely

WILMINGTON, Del.–(BUSINESS WIRE) July 23, 2021–AstraZeneca’s Bydureon BCise (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control in pediatric patients (10 to 17 years) as an adjunct to diet and exercise. The approval by the US Food and Drug Administration (FDA)

faricimab Treatment for Wet Age-Related Macular Degeneration (AMD); Diabetic Macular Edema (DME) FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) South San Francisco, CA — July 28, 2021 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced

Philadelphia, London — 26 July 2021 — GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or

ganaxolone Treatment for CDKL5 Deficiency Disorder Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update RADNOR, Pa.–(BUSINESS WIRE)–August 3, 2021 — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders,

KENILWORTH, N.J.–(BUSINESS WIRE) July 27, 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, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and

NORTH CHICAGO, Ill., July 29, 2021 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment include additional muscles of the

tenapanor Treatment for Hyperphosphatemia of Renal Failure Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis FREMONT, Calif. and WALTHAM, Mass., July 29, 2021 /PRNewswire/ – Ardelyx Inc.,(Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class

FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus 2 August 2021 — AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.1 The approval by the Food and Drug Administration (FDA) was based on

29 July 2021 — GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult

TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who

surufatinib Treatment for Neuroendocrine Carcinoma U.S. FDA Accepts Filing of Hutchmed’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 1, 2021: Hutchmed (China) Limited (“Hutchmed”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its filing

Treatment for Prader-Willi Syndrome FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome CHICAGO, IL, July 6, 2021 (Newswire.com) – Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that the

oteseconazole Treatment for Vaginal Candidiasis Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis  DURHAM, N.C.–(BUSINESS WIRE) July 28, 2021 –Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel

KENILWORTH & WOODCLIFF, N.J.–(BUSINESS WIRE) July 22, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by

News New Drug Applications FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder Treatment for Opiate Dependence FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder Plymouth Meeting, Pa. – June 26, 2021

SILVER SPRING, Md., July 28, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be

News FDA Alerts FDA Alerts Patients and Health Care Professionals About Clinical Trial Results Showing an Increased Risk of Death Associated with Pepaxto (melphalan flufenamide) July 28, 2021 Audience: Patients, Health Care Professionals July 28, 2021 — FDA is alerting patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan

sulopenem Treatment for Bacterial Infection Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem DUBLIN, Ireland and CHICAGO, July 26, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by

FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Food and Drug