March 21, 2025

FDA Approves Guselkumab for Crohn’s Disease

The FDA has approved guselkumab (TREMFYA®) for moderately to severely active Crohn’s disease, supported by Phase 3 trial data showing clinical and endoscopic superiority over ustekinumab.

Conexiant

March 13, 2025

FDA Chief Counsel Resigns Two Days In

U.S. FDA's chief counsel resigns amidst controversy surrounding her appointment and connections to mifepristone during the Biden administration.

Reuters

March 05, 2025

FDA Monthly Round-Up: Key February Updates

February's FDA approvals feature advancements in cardiology, neurology, infectious diseases, and rare disorders, including the first trials for genetically modified pig kidney transplants and novel treatments for Parkinson’s disease and spinal muscular atrophy.

Conexiant

March 04, 2025

FDA Approves Prefilled Syringe for Cortrophin Gel

FDA approves a prefilled syringe format for Purified Cortrophin Gel, reducing administration steps for patients with inflammatory and autoimmune conditions.

Conexiant

March 03, 2025

More States Fast Track Foreign-Trained Physicians

Since 2023, nine states have waived U.S. residency requirements for some foreign-trained physicians, with more states considering similar changes.

KFF Health News

April 29, 2024

Record Heat Waves Propel Surge in Heat-Related Illness

2023 brought record-breaking heat waves in the United States, significantly impacting vulnerable groups. Analysis by the CDC revealed a substantial number of heat-related illness (HRI) emergency department visits, resulting in multiple public health alerts.

Conexiant

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

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 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