OR WAIT null SECS
October 02, 2020
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
Misleading messages contribute to eroding trust in public health agencies.
The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
Symbiosis has successfully completed a scheduled inspection by MHRA.
The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.
September 28, 2020
With little more than a month to go until the national election, President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.
September 18, 2020
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.
The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.