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The FDA hopes to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More
The FDA should promote greater patient involvement in development of drugs and other treatments for diseases, the National Health Council said in a set of priority considerations for the next presidential administration. Read More
The European Medicines Agency has recommended that three medicines manufactured by Pharmaceuticals International no longer be available in the EU due to possible cross-contamination. Read More
The UK’s price watchdog recommended against expanding reimbursement for Roche’s Esbriet to early treatment of idiopathic pulmonary fibrosis, while still backing the drug for patients with moderate disease progression. Read More
The FDA granted accelerated approval to Sarepta’s Exondys 51—the first drug indicated for the treatment of Duchenne muscular dystrophy—despite reservation from FDA staff and an advisory panel. Read More
To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs. Read More