October 29, 2025

FDA Pushes Faster, Cheaper Route for Biosimilar Approval

The FDA released new draft guidance to streamline biosimilar development.

Conexiant

October 29, 2025

H-1B Visa Changes: Who Pays the Price?

New fee structure could hit hardest where physicians are needed most.

Conexiant

October 20, 2025

FDA Okays First Oral GLP-1 for CV Risk

Novo Nordisk’s once-daily GLP-1 tablet reduced major adverse cardiovascular events in high-risk adults, including those without prior heart attack or stroke.

Conexiant

October 15, 2025

Study Describes Patterns in Reported Drug Interactions

Researchers analyze about 177,000 drug interactions to identify key medication safety trends.

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