CBER's Regulatory Activity in 2018: A Reading List
The US FDA's biologics center invested heavily in preparation for coming waves of advanced therapies.
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Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.
Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.
Health-system pharmacist organization assesses the evidence behind off-label use of existing drugs for COVID-19, along with top investigational prospects like Gilead’s remdesivir.