News CDER head Tidmarsh 'on leave' and is sued by drugmaker George Tidmarsh is no longer at the helm of CDER and is facing a lawsuit claiming he abused his position there to harm a former business associate.
News Medical group advises against leucovorin for autism The American Academy of Paediatrics has warned against leucovorin as a treatment for autism, citing a lack of evidence on safety and efficacy.
News FDA plan will cut testing requirements for biosimilars The FDA has proposed a radical change to the regulatory requirements for bringing biosimilar medicines to market as a way to cut US drug prices.
News Falling flu vaccine sales in US stall CSL's Seqirus spinout CSL says flu vaccination rates in the US are expected to fall 12% to 14% this year, and have scuppered its plan to spin out its vaccines unit Seqirus.
News Texas sues J&J, Kenvue over Tylenol autism claim Texas has filed a lawsuit against J&J and Kenvue over the debunked claim that Tylenol causes autism, recently trumpeted by President Trump.
News ICER says US new drug launch prices have risen sharply ICER says the prices of new drug launches in the US rose 51% in three years, adding up to $1.5bn in first-year costs to US health systems.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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.