A Prescription Drug User Fee Act target date of May 24, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License ...

The full results of a phase 3 clinical trial showed that patients with moderate-to-severe active systemic lupus erythematosus (SLE) who received standard treatment achieved greater reductions in ...

Subcutaneous (SC) formulations of monoclonal antibodies are rapidly transforming the delivery of cancer immunotherapy. Designed to replace or complement intravenous (IV) administration, SC delivery ...

Chronic muscle tension is a common underlying factor in many pain disorders, causing reduced arterial blood flow, tissue hypoxia, and the release of inflammatory mediators. These physiological changes ...

In a merger between two subcutaneous drug delivery companies, Halozyme Therapeutics is paying $750 million in cash to acquire Elektrofi. Aside from the $750 million upfront payment, the deal also ...

Please provide your email address to receive an email when new articles are posted on . The FDA has approved a subcutaneous induction regimen of guselkumab for the treatment of adults with moderately ...

Merck (NYSE:MRK) said that the FDA has cleared Keytruda Qlex, a new subcutaneous version of its blockbuster cancer drug, offering a faster alternative to IV infusion, a company spokesperson confirmed ...

The FDA has approved Merck & Co.’s under-the-skin version of Keytruda, reducing treatment time burden for patients while granting the world’s bestselling drug potential blockbuster revenue protection.

Please provide your email address to receive an email when new articles are posted on . Patients who received subcutaneous amivantamab-vmjw every 4 weeks plus lazertinib had similar outcomes as those ...

A new analysis from the PALOMA-2 study presented today shows that subcutaneous administration of amivantamab every four weeks (Q4W), in combination with daily oral lazertinib, yields a high objective ...

TORONTO -- An investigational subcutaneous autoinjector showed comparable efficacy and safety to the IV formulation of lecanemab (Leqembi) for maintenance treatment in early Alzheimer's disease, ...