September 12, 2025

FDA Considers Ending Routine Advisory Committees on New Drugs

The FDA move to limit advisory committee involvement in drug approvals has prompted debate on the balance between efficiency and transparency.

KFF Health News

September 08, 2025

FDA Expands Indications for Von Willebrand Disease

FDA expands Vonvendi to adult routine prophylaxis (types 1 and 2) and pediatric on-demand/perioperative use.

Conexiant

September 03, 2025

Policy Shift Adjusts NIH Peer Review Role

New NIH funding rules shift decision-making power from peer review panels to political appointees in determining future scientific grants.

KFF Health News

August 28, 2025

First Generic GLP-1 for Weight Loss Approved

FDA approves Teva’s generic Saxenda (liraglutide) with adult and adolescent indications and a boxed thyroid tumor warning.

Conexiant

August 27, 2025

FDA Approves LP.8.1 COVID-19 Vaccines

LP.8.1-targeted COVID-19 vaccines for adults 65 and older and higher-risk patients were approved by the US Food and Drug Administration.

Conexiant

April 26, 2024

FDA Grants Orphan Drug Designation to Novel Pancreatic Cancer Drug Candidate

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to the novel drug candidate FL118 for the treatment of patients with pancreatic cancer.

Conexiant

April 26, 2024

Irinotecan Liposome Approved by FDA for Metastatic Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) approved irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma.

Conexiant

October 18, 2024

FDA Approves New Gastric Cancer Therapy

The FDA has approved Vyloy, a monoclonal antibody, for the treatment of gastric cancer in combination with chemotherapy, marking a significant step in targeted therapy for this disease.

Reuters

November 22, 2024

FDA Official Expects Tightened Vaccine Review

"I don't necessarily view that as a bad thing."

Reuters