Custopharm`s Generic Dicyclomine Hydrochloride Receives Approval in US
Giving advance notice of an upcoming data readout might be polite, but in Sesen Bio’s case it did not work out so well. After a run-up prompted by the group pre-announcing a call to discuss new data from its phase III trial of Vicinium, the event underwhelmed investors, who drove shares down 37%.
The US Food and Drug Administration (FDA) on Monday finalized guidance providing recommendations to drugmakers for developing new drugs and biologics to treat bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC), the most prevalent form of bladder cancer in the US.