New Nuplazid use in limbo after US knockback
Acadia becomes the latest to fall foul of the US FDA's apparently increasingly strict stance.
Merck & Co makes the accelerated approval pathway its own
Since 2010 14% of US accelerated approvals have been granted to Merck & Co’s Keytruda.
A three way battle beckons in GM1 gangliosidosis
Early data could give clues about whether gene therapies from Sio, Passage Bio or Lysogene will come out on top in this rare inherited disease.
Go or no go? Oncology decisions ahead for the FDA
The US regulator will provide verdicts on cancer projects from TG and Athenex, while Sarepta aims for its third Duchenne approval.
Gene therapy trial fails to rectify Sarepta’s sorry record
Sarepta’s first ever controlled study, of a Duchenne muscular dystrophy gene therapy, brings the markets down to earth.
Key upcoming clinical catalysts for biotech
Early 2021 will see rare diseases dominate for biotech, with Sarepta revealing key data on its gene therapy play.
