FDA halts uniQure’s plans for Huntington’s disease gene therapy
The path to approval for uniQure’s gene therapy candidate for Huntington’s disease is in doubt as the US Food and…
04 Nov 2025
Tidmarsh’s FDA exit marks latest high-profile jockeying at US agencies
George Tidmarsh has resigned from the US Food and Drug Administration (FDA), becoming the latest in a long line of high-profile leadership changes at US regulatory bodies in healthcare. Formerly…
04 Nov 2025
Kimberly-Clark buys troubled Tylenol-maker Kenvue for $48.7bn
Kimberly-Clark has agreed to acquire Johnson & Johnson (J&J) consumer health spinout Kenvue for $48.7bn. One of America’s largest consumer health companies, Kimberly-Clark said it would acquire all of Kenvue’s…
04 Nov 2025
FDA approves UCB’s Kygevvi for genetic mitochondrial disease
The US Food and Drug Administration (FDA) has approved UCB’s Kygevvi (doxecitine and doxribtimine) to treat genetic mitochondrial disease, thymidine kinase 2 deficiency (TK2d). The approval is intended to treat…
04 Nov 2025
Eli Lilly to invest $3bn in new Dutch manufacturing facility
Eli Lilly and Company has outlined plans to develop a $3bn manufacturing facility in Katwijk, situated in the Leiden Bio Science Park, the Netherlands, bolstering its worldwide supply chain operations.…
04 Nov 2025
Alvotech faces FDA setback for its Simponi biosimilar AVT05
Alvotech’s inflammation-targeting biosimilar AVT05 has been rejected by the U.S. Food and Drug Administration (FDA) because of issues with the company’s manufacturing facility in Reykjavik, Iceland. The biosimilar-focused biotech was…
03 Nov 2025
Pfizer hits Novo Nordisk and Metsera with lawsuit amid bidding war
Pfizer has followed through on its threats, filing a lawsuit against both Metsera and Novo Nordisk during a M&A bidding war for the obesity-focused biotech. This follows Novo Nordisk’s last-minute…