As US FDA recovers from aducanumab and looks towards an advisory committee on Pfizer’s COVID vaccine, it’s worth reflecting on how Office of Vaccine Research & Review Director Marion Gruber created positive turning points for the agency during a general discussion of vaccine approval standards at the VRBPAC.
The senior US FDA official at an advisory committee meeting can choose to adopt very different tactics in how they engage in the discussion, depending on the situation.
Sometimes, an office director may sit back and say nothing during an eight-hour meeting and limit their interaction to passing...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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.
