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 ...

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 ...

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

The FDA approved dupilumab for the treatment of patients 12 years and older with chronic spontaneous urticaria who remain ...

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 ...

After all, the US accounts for roughly half of the world’s healthcare expenditure and offers a realistic – albeit complex – route to reimbursement. “FDA approval is ... Australian Therapeutic Goods ...

As of now, AIM has obtained FDA approval to begin clinical trials for two ... marketed recombinant subunit control vaccines. Compared to similar products using the mRNA technology route, AIM's mRNA ...

WASHINGTON, April 2 (Reuters) - The U.S. Supreme Court on Wednesday largely backed the U.S. Food and Drug ... regulatory approval, e-cigarette companies must show their product would be ...

The FDA last year approved more than 3,000 medical ... and more than 250 applications for tobacco products, according to agency databases. The administration had been offering $25,000 buyouts ...

The Food and Drug Administration (FDA) has approved a prefilled syringe formulation of Vyvgart ® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that allows patients to self-inject the medication.