regulatory

News

GSK eyes October FDA verdict on chronic hep B drug

GSK's antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, has started a speedy FDA review that should deliver a verdict by 26th October.

News

FDA declines to approve AbbVie's Botox follow-up

AbbVie's bid to bring a rapid and shorter-acting botulinum toxin product to the US market has been knocked back by the FDA.

Market Access

weight loss injections and measuring tape

Fighting fake GLP-1s to protect patients & preserve trust

Counterfeit drug promotion is a patient safety, brand equity, and public trust issue.

News

FDA delays decision on Sanofi's subcutaneous Sarclisa

The FDA has extended its review of a new version of Sanofi's multiple myeloma Sarclisa that could help narrow the gap with arch-rival Darzalex.

News

FDA kicks off review of Roche's Gazyva for wider lupus use

Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus.

News

US President Donald Trump with the signed Order

Trump signs order to hasten psychedelic medicine access

Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.

GSK eyes October FDA verdict on chronic hep B drug

FDA declines to approve AbbVie's Botox follow-up

Fighting fake GLP-1s to protect patients & preserve trust

FDA delays decision on Sanofi's subcutaneous Sarclisa

FDA kicks off review of Roche's Gazyva for wider lupus use

Trump signs order to hasten psychedelic medicine access

Novo sues Lilly over 'misleading' GLP-1 ad campaigning

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

Editor's Picks