Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

FDA Commissioner Marty Makary announced a phaseout of eight synthetic food dyes—including Red 40—by 2026. The FDA will set ...

Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's application to initiate an Early Access Program for its investigational inhaled sed ...

Yuflyma is a high-concentration and citrate-free formulation of Humira biosimilar, approved for multiple inflammatory ...

After proper training on subcutaneous injection technique, the prefilled syringe may be administered by the patient or caregiver.

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

US FDA designates Celltrion’s Yuflyma as an interchangeable biosimilar to Humira: Incheon, South Korea Wednesday, April 16, 2025, 16:00 Hrs [IST] Celltrion, Inc. announced that ...

The U.S. Food and Drug Administration has designated Celltrion Inc.’s YUFLYMA (adalimumab-aaty), as an interchangeable biosimilar to Humira.

The US Food and Drug Administration (FDA) has designated Celltrion’s Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s Humira (adalimumab). The decision allows Yuflyma to be ...

The U.S. Food and Drug Administration (U.S. FDA) has approved Biocon Biologics’ Jobevne ... is a biosimilar to the reference product Avastin (bevacizumab). JOBEVNE is a vascular endothelial ...

Tharimmune (THAR) announced in addition to developing TH104 for the proposed indication of moderate-to-severe chronic pruritus in patients with ...