October 31, 2025

Single-Injection Omvoh Option Simplifies Ulcerative Colitis Care

The FDA approved Eli Lilly’s interleukin-23p19 antagonist Omvoh (mirikizumab-mrkz) as a once-monthly single-injection maintenance option for adults with moderately to severely active ulcerative colitis.

Conexiant

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The FDA released new draft guidance to streamline biosimilar development.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

Obinutuzumab Wins FDA Nod for Lupus Nephritis

Roche's anti-CD20 antibody improved renal response and allowed for lower corticosteroid use in the phase III REGENCY trial, offering a twice-yearly maintenance option after initial dosing.

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

May 28, 2025

Kennedy Proposes NIH Publishing Ban

"We're probably going to stop publishing in The Lancet, New England Journal of Medicine, JAMA, and those other journals because they're all corrupt."

Conexiant

June 12, 2024

USPSTF Releases Draft Osteoporosis Screening Guidelines

The USPSTF's draft recommendations reaffirm osteoporosis screening for older women, call for more research on screening men, and address health disparities.

Conexiant

September 30, 2024

Lupus Treatment Trial Paused Following Patient Deaths

Three of the fatalities showed a common pattern of symptoms and the deaths happened close to the time of dosing, while a non-fatal adverse event showed a similar proximity to dosing.

Reuters

June 20, 2024

FDA Proposes Removal of Switching Study Requirement for Biosimilars

Explore the FDA's proposed changes for biosimilar drugs and their interchangeability, including expert insights on regulatory impacts and market dynamics.

Reuters