approvals
MHRA approve new treatment combo for transplant-ineligible multiple myeloma patients
January 30, 2025Research and Development MHRA, Oncology, approvals, multiple myeloma, rare diseases
The Medicine and Healthcare products Regulatory Agency (MHRA) has approved quadruplet therapy, SARCLISA (isatuximab) in combination to treat multiple myeloma …
EMA gives market authorisation application to epilepsy treatment from Arvelle Therapeutics
March 30, 2020Sales and Marketing EMA, EMA approvals, approvals, epilepsy
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for a cenobamate adjunctive treatment of focal-onset seizures …
FDA halts overseas inspections over coronavirus concerns
March 11, 2020Research and Development, Sales and Marketing FDA, US, approvals, pharma
The FDA has responded to the ongoing COVID-19 coronavirus outbreak by announcing that it will halt all inspections of overseas …
European Commission authorises first-ever rare blood condition drug
September 4, 2018Manufacturing and Production, Sales and Marketing Europe, Sanofi, approvals, cablivi, eu commission
Sanofi have announced that the European Commission granted marketing authorisation for Cablivi (caplacizumab) for the treatment of adults experiencing an …
Top Ten most popular articles on Pharmafile.com this week
August 17, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AbbVie, CMO, Litigation, OxyContin, Purdue Pharma, approvals, top 10
This week’s pharmaceutical headlines were dominated by legal spats as the state of New York sued OxyContin drug maker Purdue …
Regulators ‘more efficient at approving drugs’
January 19, 2015Research and Development, Sales and Marketing EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters
Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis …
FDA boasts better approval rates than Europe
November 4, 2011Medical Communications, Research and Development FDA, approvals
US regulator the FDA has approved more drugs and at a faster rate than its European counterpart.A new report by …
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