Tag Archives: Approves

FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML)

FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML) Print this page Pleasanton, CA, Princeton, NJ, and Tokyo, Japan, July 7, 2020. Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved Inqovi… Read More »

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers Print this page INDIANAPOLIS, May 8, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with… Read More »

FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes

FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes Print this page SAN DIEGO – April 27, 2020 – Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Ongentys (opicapone) 25 mg and 50 mg capsules as an… Read More »

Coronavirus tracker: Hydroxychloroquine fails VA study; FDA approves at-home sample collection

Hydroxychloroquine, the medicine that gained early attention on praise from President Donald Trump and others, has failed a study in VA hospitals. Pharma’s reputation has benefited from the pandemic, and the FDA has signed off on a new at-home testing kit from LabCorp. Plus more headlines.  As of Tuesday, the number of global confirmed cases had passed… Read More »

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine Print this page HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ — Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved Audenz™ (Influenza A (H5N1)… Read More »

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED) Print this page DUBLIN–(BUSINESS WIRE)–Jan. 21, 2020– Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). Tepezza is the first and only FDA-approved medicine for… Read More »

FDA Approves New Pancreatic Treatment Found To Double Time Patients Live Without Disease Progression

Pancreatic cancer is notoriously aggressive and difficult to treat but a recent FDA ruling may help put odds more in patients’ favor. Last week the FDA approved Lynparza for use as a maintenance treatment for certain pancreatic cancer patients. The drug was found to significantly expand the amount of time patients lived without disease progression. … Read More »