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The study found that at 100 mg twice daily, the lowest approved dose for the drug, it is non-inferior to ibuprofen in the range of 600-800 mg three times daily or naproxen at 375-500 mg twice daily. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval or marketing authorization at its June meeting, including the EU’s first two CAR-T cell therapies. Read More
Roche executives said the FDA based the priority review decision on clinical trials that showed it decreases symptom duration and viral shedding. The drug is already approved for use in Japan. Read More
Regulators based the full authorization on a Phase 3 clinical trial. In the trial, Blincyto showed a superior improvement over standard of care chemotherapy. Read More
FDA Commissioner Scott Gottlieb said patients addicted to opioids who successfully transition onto medicines like buprenorphine, “aren’t swapping one addiction… Read More
ANDA applications remain sluggish while generic drug approvals creep upward after a drop at the start of the year, the FDA said, reporting 67 generic approvals and 57 ANDA applications for May. Read More
ANDA applications remain sluggish while generic drug approvals creep upward after a drop at the start of the year, the FDA said, reporting 67 generic approvals and 57 ANDA applications for May. Read More