The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog ...

Nemluvio, which was also approved for prurigo nodularis, becomes Galderma’s first approved biologic in its dermatology ...

Bristol Myers Squibb's Opdivo has been approved in a subcutaneous injection formulation by the FDA, making treatment easier for patients and potentially adding years to the product's patent life.

Oral semaglutide administered via the RaniPill® HC (RT-116) demonstrated comparable bioavailability, pharmacokinetics and ...

The FDA has approved the first and only subcutaneous apomorphine infusion device, apomorphine hydrochloride injection (Onapgo ...

The Dec. 27, 2024, Food and Drug Administration (FDA) approval of the subcutaneous injection formulation of Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for patients with solid tumors opened up ...

The biosimilar's safety and immunogenicity profiles were found to be comparable to those of the reference product in the trial.

Multiple subcutaneous doses safe and well-tolerated >69% reduction in anti-VEGF intravitreal (IVT) treatment burden in study eyes >67% ...