Category: North America

April 3, 2022 Off

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

By Author

Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.

April 2, 2022 Off

BMS’s Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial

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Bristol Myers Squibb (NYSE: BMY) has announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines at baseline.

April 2, 2022 Off

Kite’s Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

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Kite, a Gilead Company (Nasdaq: GILD), has announced the U.S. Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

March 29, 2022 Off

FDA approves Cabenuva for some adolescents living with HIV

By Dino Mustafić

US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.