News EU approval for new asthma drug Exdensur lifts GSK EU approval takes GSK a step closer to fulfilling its blockbuster sales hopes for new long-acting respiratory drug Exdensur.
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.
News Report says Jim O'Neill's time at HHS is nearing its end HHS Deputy Secretary Jim O'Neill – who is also head of the CDC – is said to be on the way out after a reshuffle of department leadership by RFK Jr.
News PTC pulls file for Duchenne therapy on FDA feedback PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.
News FDA says comparator dose scuppered Moderna's flu jab filing The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine.
News Pharvaris plans filings for HAE drug after pivotal trial win Pharvaris has reported positive data from a phase 3 trial of its drug for preventing HAE attacks, setting up marketing applications next year.
Digital Sponsored Discover a new era of healthcare panel engagement: Grounded ... A new webinar from Konovo will address some of the critical topics impacting today’s healthcare market research industry.
