The US Food and Drug Administration (FDA) has granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.) with cetuximab for certain patients with KRAS G12C–mutated colorectal […]

The European Commission (EC) has granted marketing authorization for Altuvoct (efanesoctocog alfa, Sobi) to treat and prevent bleeds and for perioperative prophylaxis in hemophilia A for […]

Truqap (capivasertib, AstraZeneca) in combination with Faslodex (fulvestrant) has been approved by the European Commission for the treatment of adult patients with:  estrogen receptor (ER)-positive, human […]

The US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa; AbbVie) for the treatment of moderately to severely active ulcerative colitis in adults. This approval […]

A new vaccine to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults has been approved by the US Food and Drug Administration.  The injectable drug, […]

The US Food and Drug Administration has expanded the indication for durvalumab (Imfinzi, AstraZeneca) to include mismatch repair deficient (dMMR) newly diagnosed advanced or recurrent endometrial […]

The US Food and Drug Administration has granted accelerated approval to repotrectinib (Augtyro, Bristol Myers Squibb) for all locally advanced, unresectable, or metastatic solid tumors with […]

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) for patients weighing ≥ 63 kg […]

The US Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor; Ipsen) for treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic […]