News FDA starts review of Regeneron's drug for rare disease FOP Can Regeneron's drug for ultra-rare bone disease FOP pick up the baton from Ipsen's Sohonos, whose growth has stalled?
News Makary says FDA will "end two-trial dogma" for approvals The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials.
News FDA relents and will review Moderna's flu shot The FDA will start a review of Moderna's flu jab mRNA-1010, after refusing to accept the filing last week, with a new "regulatory approach."
News FDA starts review of BMS's 'celmod' for multiple myeloma Bristol Myers Squibb could be months away from bringing the first 'celmod' to market, as the FDA starts a review of iberdomide for multiple myeloma.
News UK seeks views on indefinite CE marks for medical devices The UK has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in GB should be recognised indefinitely.
News FDA turns down 'national priority' drug from Disc Medicine One of the beneficiaries of the FDA's national priority vouchers, Disc Medicine, has had its marketing application turned down by the regulator.
Patients LSX2026: On promise and patience, with Hans Schambye At LSX World Congress 2026 in Lisbon, Portugal, web editor Nicole Raleigh spoke with Hans Schambye, CEO of BOOST Pharma.
Sales & Marketing Sponsored Using AI-driven synthetic personas to take your insights fur... As AI continues to reshape the healthcare landscape, pharma teams are beginning to leverage synthetic personas.
