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The FDA is taking issue with a new study that says the agency can’t tell if its risk evaluation and mitigation strategy (REMS) program for extended-release and long-acting opioids is effective. 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
Lawmakers failed to enact drug pricing legislation in 2019 but they will be under intense pressure to try again in the new year as presidential campaigns begin to pick up steam. Read More
In observance of the holiday season, Drug Industry Daily will not be published Wednesday, Jan. 1. The next issue will be published Thursday, Jan. 2. Read More
The FDA found serious violations at Sun Pharma’s Halol, Gujarat facility in an inspection earlier this month, hitting the company with a Form 483 for issues ranging from data integrity to employee training. Read More