Tag Archives: approval

FDA Gives Accelerated Approval for Risky Alzheimer’s Pill

The U.S. Food and Drug Administration granted accelerated approval for the Alzheimer’s disease drug lecanemab (Leqembi). The drug, a monoclonal antibody, binds to amyloid beta in the brain. An 18-month study published in the New England Journal of Medicine1 found Leqembi reduced markers of amyloid in early Alzheimer’s disease and led to “moderately less decline”… Read More »

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis

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 »

FDA opens private Covid vaccine meetings to the public in bid to gain trust as Trump pressures for fast approval

The FDA took the unusual step Thursday in opening to the public a routine meeting with an advisory group that’s weighing in on approving the coronavirus vaccine as the agency battles public concerns about its safety as well as political pressure from President Donald Trump to approve it before the Nov. 3 election. The Vaccines… Read More »

Apervita’s NCQA approval helps health plans speed VBC analysis

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 »

Promising new sickle cell disease medicine wins FDA approval

This undated image provided by Novartis shows bottles of Novartis’s Adakveo. U.S. regulators have approved the new sickle cell disease medicine that can prevent extremely painful, dangerous “crises” in which misshapen blood cells clump together, reducing blood and oxygen flow. (Novartis via AP) After a recent decision by the FDA a better day could be… Read More »