Setmelanotide, which is being developed to treat insatiable hunger and early-onset severe obesity in people with rare genetic disorders, was also recently submitted to the US regulator for approval.
Rhythm Pharmaceuticals has asked the European Medicines Agency to fast-track its planned EU marketing authorization application (MAA) for setmelanotide, an investigational treatment for rare genetic disorders of obesity.
The EMA, which accepted setmelanotide on its priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster in 2018, was this week due to consider whether...
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
