The U.S. Food and Drug Administration approved Novartis’ first-in-class Scemblix (asciminib) for two indications in the treatment of chronic myeloid leukemia (CML).
AstraZeneca’s Saphnelo (anifrolumab-fnia) was approved in the United States for the treatment of adult patients with moderate to severe systemic lupus erythematosus who are receiving standard therapy.
Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced July 29 the company’s BiovitalsHF solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved Apellis Pharmaceuticals’ Empaveli as the first targeted C3 therapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration granted BOLD-100 an Orphan Drug Designation (ODD) in the treatment of gastric (stomach) cancer.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel) as the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma.
Shares of Ovid Therapeutics soared in trading after the company announced pharma giant Takeda signed a licensing agreement valued at $856 million to secure global rights to the investigational medicine soticlestat for the treatment of two forms of rare epilepsy.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva as the only complete long-acting regimen for the treatment of HIV-1 infection in adults.
The U.S. Food and Drug Administration approved Karyopharm Therapeutics Inc.’s Xpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.