Pink SheetThe median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug User Fee Act goals, highlighting the fundamental predictability of the re
Pink SheetThe US FDA convened five advisory committee meetings to discuss NMEs and novel biologics during the first half of the year. Two of the meetings took place after the user fee goal date had passed, sugg
Pink SheetThe US Food and Drug Administration beats the European Medicines Agency to approval of novel agents across the board, but the imbalance is even more stark in oncology, the largest therapy area, a Pin
Pink SheetTwo newly announced June dates go some way to alleviating the recent drought in advisory committee meetings outside oncology. Both gatherings of committees under the Office of Neuroscience promise fir