Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
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Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
Scientists reveal 76 percent of critically ill trial participants treated with convalescent plasma are recovering, with almost half now discharged from hospital.
Researchers reveal their experimental test can detect the presence of COVID-19 RNA in a sample in 10 minutes, and in a way that does not require trained personnel to interpret.
CYRAMZA in combination with erlotinib was approved as a first-line treatment for metastatic EGFR-mutated non-small cell lung cancer.
The US FDA approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) gel, the first non-hormonal, vaginal pH regulator contraceptive.
Lynparza’s approval was based on results from a Phase III clinical trial in which it improved overall survival and progression-free survival in patients with certain prostate cancers.
Research suggests almost 70 percent of global clinical trials have been disrupted by enrolment suspensions caused by the COVID-19 pandemic.
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
A team has revealed that a patient who received induced pluripotent stem cells to replace lost dopaminergic neurons has reduced symptoms of Parkinson's disease.
A double-blind clinical trial has begun in the US to study hydroxychloroquine and azithromycin treatment in patients with COVID-19.
The US FDA has given Fast Track Designation to Moderna's mRNA vaccine candidate, mRNA-1273, designed to protect against COVID-19.
A new report has found that in 2019 the FDA approved 119 new drugs and biologics, but that this is down from 137 in 2018, impacting contract manufacturing organisations.
The US FDA has announced ICU Medical is recalling a lot of Lactated Ringer's Injection due to iron oxide particulates being found by a consumer.
The FDA has approved Tabrecta (capmatinib) for patients with metastatic non-small cell lung cancer whose tumours have a mutation that leads to MET exon 14 skipping.
The CDMO AMRI has said it will boost its production of the malaria drug hydroxychloroquine sulfate, identified as a potential COVID-19 treatment, following an emergency use authorisation from the FDA.