Tag Archives: Approves

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) BOSTON, July 20, 2021 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in… Read More »

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Tembexa (brincidofovir) tablets and oral suspension approval… Read More »

FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma LAUSANNE, Switzerland–(BUSINESS WIRE) APRIL 23, 2021 — ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after… Read More »

FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma

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… Read More »

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain Print this page ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults… Read More »