Roche’s novel cancer immunotherapy tiragolumab was granted breakthrough therapy designation by the U.S. Food and Drug Administration in combination with the Swiss drugmaker’s Tecentriq in the treatment of non-small cell lung cancer.
Novartis received the U.S. Food and Drug Administration’s Breakthrough Therapy tag for the company’s experimental medicine iptacopan, which the Swiss drugmaker hopes wins approval to treat the rare blood disorder paroxysmal nocturnal hemoglobinuria.
Topline results from Gilead Sciences’ Phase II/III CAPELLA trial show that treatment with the company’s long-acting HIV-1 capsid inhibitor lenacapavir reduces HIV viral load better than placebo in heavily treated patients living with multidrug resistant HIV-1 infection.
AstraZeneca and Daiichi Sankyo’s Enhertu received supplemental Biologics License Application (sBLA) acceptance and U.S. priority review for the treatment of HER2-positive metastatic gastric cancer.
Inventiva, with headquarters in Daix, France, received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the company’s lanifibranor for nonalcoholic steatohepatitis (NASH).
The U.S. Food and Drug Administration granted Breakthrough Therapy designation to Genentech’s Esbriet as a potential treatment for adults with unclassifiable interstitial lung disease (uILD) as the Roche subsidiary looks to expand the drug’s indications.
The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.
Shares of Theratechnologies and TaiMed Biologics jumped after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
Merck KGaA and Pfizer Inc. announced that the U.S. FDA granted Breakthrough Therapy Designation for avelumab in combination with Inlyta (axitinib) treatment-naïve patients with advanced renal cell carcinoma.
Novartis said the U.S. Food and Drug Administration granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery.