Immunotherapy has shown a 27% reduction in mortality for patients with limited-stage small cell lung cancer, based on Phase ...
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...
Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...
Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...
If authorised, Vimkunya would be the first vaccine in the EU to protect adolescents aged 12 to 17 against Chikungunya.
The ruling requires all trials across the EU to be filed through the European Medicines Agency’s digital filing system.
Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public ...
The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
AstraZeneca (AZN) stock in focus as its partner Daiichi Sankyo (DSNKY) wins EU backing for their jointly developed breast ...