RxNews®

May 13, 2026 - The FDA announced the approval of Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), for two separate indications in adults with HER2-positive early-stage breast cancer Enhertu followed by a taxane, trastuzumab, and pertuzumab for the neoadjuvant treatment of adult patients with HER2-positive Stage II or III breast cancer as determined by an FDA-authorized test; and adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.

May 13, 2026 - The FDA approved AstraZeneca’s Fasenra (benralizumab), for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause.

May 13, 2026 - The FDA announced the approval of Taiho Oncology’s Inqovi (decitabine/cedazuridine), in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

May 15, 2026 - The FDA announced the approval of Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab/hyaluronidase-tqjs), as adjuvant treatments of adult patients with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.

May 12, 2026 - The FDA approved Merck’s Zerbaxa (ceftolozane/tazobactam), for the treatment of adult and pediatric patients (at least 32 weeks gestational age) with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.

May 18, 2026 - AstraZeneca announced the FDA approval of Baxfendy (baxdrostat), in combination with other antihypertensive drugs, for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents.

May 13, 2026 - The FDA announced the approval of BeOne Medicines’ Beqalzi (sonrotoclax), for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

May 7, 2026 - The FDA approved Accord’s Ennumo (pegfilgrastim-pccg), biosimilar to Amgen’s Neulasta® (pegfilgrastim).

May 18, 2026, Accord BioPharma announced the FDA approval of Immgolis and Immgolis Intri (golimumab-sldi), biosimilar and interchangeable to Janssen’s Simponi® and Simponi Aria® (golimumab).

May 18, 2026 - Chiesi announced the FDA approval of Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate), for the maintenance treatment of asthma in adult patients aged 18 years and older.