May 27, 2025

New FDA approved Biosimilar Targets IL-12/23

The FDA has approved Starjemza, a ustekinumab biosimilar, for multiple inflammatory conditions.

Conexiant

May 20, 2025

FDA Releases Guidance to Accelerate Generic Drugs

The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."

Conexiant

May 05, 2025

Ustekinumab Biosimilar Receives Interchangeability Approval

Selarsdi (ustekinumab-aekn) was approved by the FDA as an interchangeable biosimilar to Stelara (ustekinumab) for all approved indications, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Conexiant

May 05, 2025

FDA Monthly Round-up: Key April Updates

April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.

Conexiant

April 29, 2025

New Oral Option Approved for GCA

The FDA approved Rinvoq (upadacitinib) as the first and only oral Janus kinase inhibitor for the treatment of giant cell arteritis in adults, providing a steroid-sparing option for achieving sustained remission.

Conexiant

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

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

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