EU Decision Time For Teclistamab & Seven Other Drugs; Incyte Withdraws Parsaclisib Filing
Janssen’s bispecific antibody, teclistamab, and Eli Lilly’s potential blockbuster diabetes drug, tirzepatide, are among the products that are this week up for an opinion by the European Medicines Agency on whether they should be approved in the EU.
You may also be interested in...
The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances.
The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
Keeping Track: US FDA Okays Alnylam’s siRNA Amvuttra, Alopecia Claim For Lilly’s Olumiant; Sierra Submits Momelotinib
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.