Apr 08, 2022 By Jazmine Colatriano, M.S. BioSpace Johnson & Johnson’s Janssen Pharmaceutical secured an arbitrary win regarding royalty decisions stemming from the licensing and marketing of daratumumab, an anti-CD38 monoclonal antibody treatment […]
The U.S. Food and Drug administration granted priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
The U.S. FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth shot of the Pfizer-BioNTech and Moderna COVID-19 vaccines for everyone 50 years of age and older.
Tetra Bio-Pharma announced that the company’s investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the U.S. Food and Drug Administration, which brings the aerosol botanical therapy closer to marketing approval.
Incyte Corporation reported that the U.S. Food and Drug Administration pushed back the review of the company’s supplemental New Drug Application for Opzelura (ruxolitinib cream) for vitiligo.
AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
The U.S. Food and Drug Administration placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial, which is evaluating davoceticept (ALPN-202) in combination with Merck’s immunotherapy pembrolizumab (Keytruda) in adults with cancer.
After months of speculation about looming layoffs, Biogen is handing out pink slips in order to save about $500 million.
The U.S. Food and Drug Administration rejected Reata Pharmaceuticals’ New Drug Application for the company’s proposed chronic kidney disease drug, citing a lack of proof of effectiveness.
Reuters Health