In response to the coronavirus pandemic knocking Shingrix off its juggernaut course, GlaxoSmithKline plans a “relaunch” to get the rising star vaccine back on its upward trajectory. Now, that effort has received a boost as the FDA on Monday approved the shingles vaccine in adults age 18 and older who are immunocompromed and thus are at a greater… Read More »
BALTIMORE, July 1, 2021 /PRNewswire/ –Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis… Read More »
Value-based care platform provider Apervita says it is the first company to be certified by the National Committee for Quality Assurance for electronic clinical quality measures using a clinical quality language-based engine. The company’s newly certified CQL-based engine—based on HL7 logic standards that support both eCQMs and clinical decision support—can be adopted by healthcare organizations… Read More »
FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s… Read More »