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December 12, 2019
Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.
December 02, 2019
A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.
Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
November 14, 2019
NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.
November 02, 2019
An effective quality control unit is independent from manufacturing and ensures current standards are followed.
After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.
Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.
October 24, 2019
Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.
CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.
CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.