The FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted in support of Esketamine nasal spray CIII for adults living with treatment-resistant depression. The decision came as a result of 14 yes votes, two no votes and one abstain, basing their support on the safety and efficacy data from
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The FDA has accepted two new antibacterial drug applications from Merck & Co, both of which have received Priority Review. The first is for the company’s combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible
NICE and EMIG are working together to increase understanding of the services the Institute offers the life sciences industry. The collaboration also aims to open up a new channel for the industry to give feedback to NICE to inform any review, monitoring or refinement of its processes. The partnership will run as a pilot scheme