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FDA Commissioner Robert Califf warned that the agency’s accelerated approval pathway is in dire need of reform during remarks at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit held earlier this week. Read More
An FDA advisory committee recommended 14-1 yesterday that the FDA withdraw accelerated approval for Covis Pharma’s preterm birth drug Makena. Read More
The FDA has updated two compliance program guidances that provide instructions for agency staff conducting inspections, adding provisions for use of alternative inspection tools as well as bringing them into closer alignment with International Council for Harmonization (ICH) quality guidelines. Read More
Eli Lilly plans to further expand into gene therapies with the $487 million purchase of Massachusetts-based biotech Akouos, a company developing gene treatments for hearing loss. Read More
The FDA has postponed its decision date on Travere Therapeutics’ new drug application (NDA) for sparsentan by three months, pending an update of the drug’s risk evaluation and mitigation strategies (REMS) plan. Read More
Ublituximab — TG Therapeutics’ potential blockbuster infusion for multiple sclerosis (MS) — is probably more clinically effective than the approved oral disease-modifying therapies but wouldn’t be cost-effective if priced the same as Roche’s Ocrevus at $55,081 per year. Read More