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The FDA announced the launch of Elsa 4.0, an upgraded internal AI tool now available to all agency staff including scientific reviewers and investigators. The initiative is part of…
The FDA announced a pilot program for one-day inspectional assessments to make its inspectional resources more targeted and efficient. The initiative is part of the agency's broade…
# FDA Approves Sandoz Generic Drug Application Sandoz has received FDA approval for ANDA212069, expanding its generic drug portfolio and positioning the company to capture additio…
# FDA Approves Sandoz Generic Drug Application Sandoz has received FDA approval for its abbreviated new drug application (ANDA 212068), expanding the company's generic portfolio a…
The FDA approved the marketing of four Glas ENDS products through the premarket tobacco product application pathway. This authorization expands market access for the company's elec…
Zhejiang Novus announced the receipt of FDA approval for its ANDA, a strategic milestone expected to bolster the company’s commercial portfolio and drive significant revenue growth…
# FDA Approves Caplin Steriles Limited's Intravenous Calcium Gluconate Generic The FDA has approved Caplin Steriles Limited's abbreviated new drug application for intravenous calc…
# FDA Approves Generic Drug Application from Yichang Humanwell Yichang Humanwell has received FDA approval for an abbreviated new drug application (ANDA220529), positioning the Ch…
The FDA issued a 'safe to proceed' letter to Revolution Medicines for an expanded access treatment protocol of daraxonrasib, an experimental pancreatic cancer drug. The authorizati…
Federal banking agencies have released loan-to-deposit ratios for host states, providing updated metrics on lending activity relative to deposits across different jurisdictions. Th…
# FDA Approves Arvinas' VEPPANU (Vepdegestrant) for Oral Administration Arvinas Operations, Inc. received FDA approval for VEPPANU (vepdegestrant), an oral selective estrogen rece…
# FDA Approves New Drug Application for Apotex Apotex received FDA approval for NDA220837 on May 1, 2026, positioning the Canadian pharmaceutical manufacturer to capture additiona…
# FDA Approves Incyte's JAKAFI XR Extended-Release Formulation Incyte Corporation received FDA approval for JAKAFI XR (ruxolitinib), an extended-release oral formulation of its fl…
MICRO LABS secured FDA approval for ANDA217239, a regulatory clearance that is expected to diversify the company's product portfolio and generate incremental sales revenue as the p…
FDA has approved the generic version of the referenced drug manufactured by IPCA LABS LTD, representing a new entry in the market. The anticipated approval creates a competitive la…
The FDA approved an expanded use for Auvelity (dextromethorphan/bupropion) to treat agitation associated with Alzheimer's dementia in adults. This marks the first non-antipsychotic…
The FDA is proposing to remove semaglutide, tirzepatide, and liraglutide from the 503B bulks list, determining there is no clinical need for outsourcing facilities to compound thes…
# FDA Approves Generic Sitagliptin and Metformin Hydrochloride Combination Apotex Corp. received FDA approval for its generic sitagliptin and metformin hydrochloride combination t…
# FDA Approves BPI Labs' Generic Fluorescein Sodium for Intravenous Use The FDA has approved BPI Labs LLC's abbreviated new drug application for generic fluorescein sodium injecti…
UNICHEM announced FDA approval of ANDA 219593 effective April 30, 2026, a milestone expected to bolster its market presence and diversify its revenue streams within the generic pha…