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

February 24, 2025

Game-Changer for Pfizer? Former FDA Drug Chief Takes Reins

Before leadership at the FDA, Dr. Patrizia Cavazzoni spent nearly 2 decades in the pharmaceutical industry.

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

January 15, 2025

Bertagnolli to Exit NIH Director Role

NIH director, Dr. Monica M. Bertagnolli, is stepping down after launching major initiatives in women's health and long COVID research, indicating optimism for their continuation under new leadership.

Conexiant