The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]
AstraZeneca has received European Commission approval for a new subcutaneous formulation of Saphnelo (anifrolumab), allowing adult patients with systemic lupus erythematosus (SLE) to self-administer the drug via a once-weekly pre-filled pen. The regulatory decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is supported by data from the Phase […]
Pfizer Inc. has moved a step closer to reshaping the treatment paradigm for one of hemophilia’s most challenging patient subgroups. The company’s investigational therapy HYMPAVZI (marstacimab) demonstrated a 93 percent reduction in bleeding episodes in patients with hemophilia A or B who have developed inhibitors, according to data presented at the 67th American Society of […]
