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May 03, 2019
Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
May 02, 2019
New agency leadership is pressed to promote innovation while addressing safety and quality issues.
May 01, 2019
The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.
A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.
April 30, 2019
Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.
The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.
April 18, 2019
CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.