regulatory

News

The FDA has cleared another generic of the abortion pill mifepristone, as it carries out a review of the drug that has been criticised as spurious.

News

A pioneer of in vivo cell therapy, Umoja has cleared another regulatory milestone by getting fast-track status for its lead blood cancer programme.

News

The Trump administration's linking of autism to Tylenol and vaccines with no evidence raises concern about an FDA review of mifepristone's safety.

News

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

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 legal hurdles does the FDA face in changing the rules for broadcast advertising? And what should the industry be doing to prepare for changes?