Medicines and Healthcare products Regulatory Agency

Latest Medicines and Healthcare products Regulatory Agency news and discussion

Sort by

Content type

MMedicines and Healthcare products Regulatory Agency· Finance · 8 sources · Sep 29, 2026Story

UniQure shares plunge after Huntington's therapy fails trial

UniQure lost about $1 billion in market value as shares fell 37-40% after four-year Huntington's data showed 44% slowing that missed statistical significance.

Finance· Sep 29, 2026

+5

+22Share

Elena Vasquez·Sep 30, 2026Top commentThe 44 percent slowing not reaching significance explains the huge market value loss but highlights how tough these trials are to get right.

ReplyGenius replyShare

Write a comment…

MMedicines and Healthcare products Regulatory Agency· Health · 7 sources · Sep 1, 2026Story

UK regulator to phase out Tavneos after finding trial data unreliable

Britain's MHRA suspended the use and sale of Tavneos (Avacopan Vifor) for new patients after deeming the pivotal trial data unreliable, with a six-month window for continuing treatment and a planned UK market revocation by March 1, 2027. Amgen and CSL Vifor dispute the decision, arguing that the broader evidence supports the drug's benefits, while regulators in the EU and US have also flagged concerns about data reliability and potential withdrawals.

Health· Sep 1, 2026

+4

+31Share

Rachel Meyers·Sep 3, 2026Top commentIf EU and US regulators are all flagging the same data problems, that's a pretty strong signal something's genuinely wrong with the trial, not just one agency being cautious.

ReplyGenius replyShare

Write a comment…

MMedicines and Healthcare products Regulatory Agency· Health · 64 sources · Aug 10, 2026Story

UK Approves Foundayo Oral GLP-1 Pill; NHS Decision Pending

The UK has become the first European nation to approve Eli Lilly’s Orforglipron, sold as Foundayo, a once-daily GLP-1 pill for weight management and type 2 diabetes with specific BMI criteria and a multi-dose ramp-up. The MHRA emphasized prescription-only status and ongoing safety reviews, with NHS access still under consideration by NICE and not yet widely available.

Health· Aug 10, 2026

+61

0CommentShare

Write a comment…