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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
In the EU, biosimilars are poised to join the main market as prescribers widely embrace the lower-cost, copycat versions of the brand-name drugs. Read More