USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License...
USA – FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
USA – Califf: FDA committed to boosting complex generic drug development
Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase...
USA – Prenatal cannabis exposure associated with mental disorders in children that persist into...
Prenatal cannabis exposure following the middle of the first trimester—generally after five to six weeks of fetal development—is associated with attention, social, and behavioral...
UK – MSD’s pembrolizumab therapy gets NICE approval
An estimated 1,500 people aged 12 years and over with melanoma are set to benefit from MSD’s – known as Merck & Co in the...
International – Genetically modified herpes combats advanced cancers
Researchers have found that RP2 – a modified version of the herpes simplex virus – has showed signs of effectiveness in a quarter of...
France – Covid-19 : la HAS intègre les vaccins bivalents dans la stratégie de...
La HAS confirme sa recommandation d’administrer une dose additionnelle de vaccin contre la Covid-19 aux personnes à risque de faire une forme sévère de...
Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants
The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to...
Europe – Biosimilar medicines can be interchanged
EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference...
