Financial News Archive

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Federal
Federal Reserve approves applications by Columbia Bank MHC and Columbia Financial

The Federal Reserve Board has approved related applications submitted by Columbia Bank MHC and Columbia Financial, Inc. The approval allows these enti...

FDA
FDA Approves Bizengri for Rare Bile Duct Cancer Under Priority Program

The FDA granted approval for Bizengri (zenocutuzumab-zbco), marking the seventh approval under the National Priority Voucher Pilot Program. The drug t...

FDA
FDA Issues Guidance on Postapproval Pregnancy Safety Studies for Drugs

The FDA released final guidance recommending methodologies for studying drug and biologic safety during pregnancy in the postapproval setting. The gui...

FDA
FDA Launches Elsa 4.0 AI Tool, Completes Data Platform Consolidation

The FDA announced the launch of Elsa 4.0, an upgraded internal AI tool now available to all agency staff including scientific reviewers and investigat...

FDA
FDA Pilots One-Day Inspectional Assessments to Boost Oversight Efficiency

The FDA announced a pilot program for one-day inspectional assessments to make its inspectional resources more targeted and efficient. The initiative ...

FDA
FDA Authorizes Four Glas Electronic Nicotine Delivery System Products

The FDA approved the marketing of four Glas ENDS products through the premarket tobacco product application pathway. This authorization expands market...

FDA
FDA Clears Expanded Access for Revolution Medicines' Pancreatic Cancer Drug

The FDA issued a 'safe to proceed' letter to Revolution Medicines for an expanded access treatment protocol of daraxonrasib, an experimental pancreati...

Federal
Federal Reserve Agencies Issue Host State Loan-to-Deposit Ratios

Federal banking agencies have released loan-to-deposit ratios for host states, providing updated metrics on lending activity relative to deposits acro...

Arvinas
FDA Approves VEPPANU — Arvinas Operations, Inc.

# FDA Approves Arvinas' VEPPANU (Vepdegestrant) for Oral Administration Arvinas Operations, Inc. received FDA approval for VEPPANU (vepdegestrant), a...

FDA
FDA Approves Auvelity as First Non-Antipsychotic for Dementia-Related Agitation

The FDA approved an expanded use for Auvelity (dextromethorphan/bupropion) to treat agitation associated with Alzheimer's dementia in adults. This mar...

FDA
FDA Proposes to Exclude Semaglutide, Tirzepatide, Liraglutide from 503B Bulks List

The FDA is proposing to remove semaglutide, tirzepatide, and liraglutide from the 503B bulks list, determining there is no clinical need for outsourci...

Federal
Federal Reserve releases FOMC statement on monetary policy

The Federal Reserve's Federal Open Market Committee issued a statement regarding monetary policy decisions. The statement addresses current economic c...

FDA
FDA Completes Largest-Ever Testing of Infant Formula for Chemical Contaminants

The FDA released results from its largest and most rigorous examination of chemical contaminants in infant formula available in the U.S. market. The c...

FDA
FDA Announces Major Steps to Implement Real-Time Clinical Trials

The FDA announced two major steps to advance real-time clinical trials (RTCT) implementation. The initiative aims to modernize clinical trial processe...

Federal
Federal Reserve Approves OceanFirst Financial Corp. Application

The Federal Reserve Board has approved an application submitted by OceanFirst Financial Corp. The approval permits the company to proceed with its req...

Federal
Federal Reserve Approves Banco de Credito del Peru Application

The Federal Reserve Board has approved an application submitted by Banco de Credito del Peru. The approval allows the Peruvian financial institution t...

FDA
FDA Accelerates Mental Illness Treatments Following Trump Executive Order

President Trump issued an Executive Order on April 18 directing HHS to accelerate access to treatments for serious mental illness, including treatment...

Federal
Federal Reserve Finalizes Community Bank Leverage Ratio Changes

The Federal Reserve and banking agencies have finalized modifications to the community bank leverage ratio framework. The changes are designed to enha...

FDA
FDA Approves Otarmeni, First Gene Therapy for Genetic Hearing Loss

The FDA approved Otarmeni (lunsotogene parvec-cwha), marking the first dual AAV vector-based gene therapy for genetic hearing loss treatment. The appr...

FDA
CMS and FDA Launch RAPID Coverage Pathway for Breakthrough Medical Devices

CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to accelerate Medicare patient access to ...