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

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

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

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

Argenx’s VYVGART Hytrulo prefilled syringe for self-injection has received FDA approval for the treatment of adult patients ...

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

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

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 ...

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 ...

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