News FDA knocks back Biogen's high-dose Spinraza Biogen's efforts to defend its SMA business have been dealt a setback after the FDA declined to approve a high-dose version of Spinraza.
News Manufacturing issues block FDA nod for Scholar Rock SMA drug Unresolved issues at a manufacturing plant operated by Novo Nordisk have led to a complete response letter for Scholar Rock's SMA drug apitegromab.
Sales & Marketing What can FDA really do about DTC pharma advertising? What legal hurdles does the FDA face in changing the rules for broadcast advertising? And what should the industry be doing to prepare for changes?
News Flood of warning letters follows DTC ad clampdown The FDA has lost no time following through on its plan to tighten up DTC advertising of medicines, sending out dozens of untitled and warning letters.
News FDA's Makary explains 'overdue' pharma ads crackdown FDA Commissioner Marty Makary has called DTC ads for medicines a "public health crisis" as the industry prepares for a regulatory crackdown.
News RFK Jr expands ACIP ahead of highly anticipated meeting Five members have been added to a controversial CDC vaccines panel ahead of a meeting this week that could have an impact on US immunisation policy.
R&D The long-delayed promise of the microbiome, with Sam Possemi... Sam Possemiers, CEO of MRM Health, believes that the microbiome space is finally coming into maturity.
Sales & Marketing Sponsored How to meet your physicians where they are online A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.
