The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
For the US Food and Drug Administration, the dog days of summer came late. The highlight of a sleepy week in drug approvals was a new orphan indication for GlaxoSmithKline plc’s Nucala (mepolizumab).
On the submission front, Bristol Myers Squibb Company and bluebird bio had good news to report on the BLA for the chimeric antigen receptor T-cell (CAR-T) therapy idecabtagene...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
