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Valtoco was approved for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure. Read More
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee split yesterday in a 6-6 vote over Durect’s Posirim (bupivacaine extended-release solution) for post-surgical analgesia. Read More
It may be time to simplify the FDA’s many expedited review programs, according to a Harvard research team that studied the agency’s drug reviews over the past four decades. Read More
The EMA authorized fewer new active substances and orphan drugs in 2019 than in the previous year, according to the agency’s highlights released yesterday. Read More
CDER Director Janet Woodcock flagged 2019 as a strong year for novel drug approvals, although the total dipped to 48 from the ten-year record of 59 for 2018. Read More
Merck is expecting a decision from the FDA in January on a supplemental NDA for its blockbuster oncology drug Keytruda (pembrolizumab) for treatment of high-risk, non-muscle invasive bladder cancer. Read More
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