Treatment for Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy January 14, 2019 – Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of […]Continue Reading ...
Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. […]Continue Reading ...
Treatment for Postoperative Pain FDA Grants Priority Review Designation for Heron Therapeutics’ NDA for HTX-011, a Non-Opioid for Postoperative Pain Management SAN DIEGO, Dec. 31, 2018 /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 […]Continue Reading ...
Pharmaxis Announces Resubmission of Bronchitol NDA Sydney, Australia — December 20, 2018 — Pharmaceutical research company Pharmaxis (ASX: PXS) today announced the resubmission of the Bronchitol New Drug Application with the United States Food and Drug Administration (FDA) by its licensee Chiesi Group (Chiesi). The resubmission responds to the matters raised by the FDA in […]Continue Reading ...
The U.S. Food and Drug Administration today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. “Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed […]Continue Reading ...
Treatment for Iron Deficiency Shield Therapeutics Announces the NDA for Feraccru has been Accepted for Filing and Review by FDA London, UK, 3rd December 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs, today announces that the US Food and Drug Administration (FDA) has […]Continue Reading ...
A federal court ordered a Michigan-based food manufacturer to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the U.S. Food and Drug Administration and Michigan Department of Agriculture and Rural Development, which found Listeria monocytogenes (L. mono) in the company’s food preparation […]Continue Reading ...
SOUTH SAN FRANCISCO, Calif., Dec. 03, 2018 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (GBT) (Nasdaq: GBT) today announced that the U.S. Food and Drug Administration (FDA) has informed GBT through discussions and written correspondence that the agency agrees with the Company’s proposal relating to use of an accelerated approval pathway for voxelotor for the […]Continue Reading ...
NEWTOWN, Pa., Jan. 02, 2019 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on MDS, today announced that it has submitted a Special Protocol Assessment request to the U.S. Food and Drug Administration (FDA) for a Phase […]Continue Reading ...
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Announces Safety Monitoring Measures for Essure Birth Control Device The U.S. Food and Drug Administration is implementing a number of steps for long-term safety monitoring of the permanent birth control device Essure, which will no longer be […]Continue Reading ...
THOUSAND OAKS, Calif., Dec. 14, 2018 /PRNewswire/ — Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an […]Continue Reading ...
The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, […]Continue Reading ...
Critical Path Institute (C-Path) announced today that its Type 1 Diabetes (T1D) Consortium has received a positive response to its Letter of Intent (LOI) from the U.S. Food and Drug Administration (FDA) detailing the FDA’s decision to accept the consortium’s Biomarker Initiative project into the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program […]Continue Reading ...
FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE) December 14, 2018 –Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin®1 (trastuzumab) for the following indications: Adjuvant Breast Cancer of HER2 […]Continue Reading ...
Dec 12 2018 The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed […]Continue Reading ...
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- Columbia Medical Student Receives McDonogh Scholarship
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- Plant based diet could be the best option for the planet says commission
- New conservation practice could reduce nitrogen from agricultural drainage, study shows
- UIC researchers receive $1.7 million NCI grant to study Southeast Asian fruit
- New study determines the fate of DNA derived from genetically modified food
- Scientists develop new gene therapy that prevents axon destruction in mice
- Study finds critically low HPV vaccination rates among younger adolescents in the U.S.
- Brain cells involved in memory play key role in reducing future eating behavior
- Risk for Conversion of MS Varies With Different Therapies
- Investigational cream may help patients with inflammatory skin disease
- Medical school news office receives six writing awards | News Center