Flow Neuroscience launched its FDA-approved at-home tDCS device FL-100 in the US this week at a patient cost of $2,200 for an ...

Frazier Life Sciences raised another $1.1bn for its Public Fund, bringing total capital commitments to $2.8bn. Also, two ...

President Trump's Most Favored Nation drug pricing deals will face their first sustained public scrutiny when agreement ...

The biotech unveiled positive data for what it called the first monoclonal antibody that targets Tmprss6, the same target as ...

Implantica is launching RefluxStop in the US after a PMA approval that was based entirely on European trial data. A Medicare ...

The FDA's benefit-risk framework for opioid analgesics must weigh the harms of under-treated pain and restricted access along ...

Singapore is planning to streamline its health regulatory framework into a single authority, giving companies, innovators and ...

Pharma groups have welcomed plans to give quality, innovation and resilience greater weight under the newly proposed Public ...

Merck wants a 180-day runway, instead of the usual 30 days, to relabel and clear schedule IV inventory, while Eisai said the dual orexin receptor antagonist class should be removed from all Controlled ...

CDRH’s Rare Disease Impact Initiative seeks to advance the development and authorization of devices to treat rare diseases.

The German health system is broaching self-pay for certain diagnostics in certain settings. On one hand, it widens access, ...

The European Medicines Agency wants marketing authorization application filing dates to be jointly agreed with companies ...