AstraZeneca withdraws application for lung cancer drug in EU
AstraZeneca has voluntarily withdrawn its marketing authorisation application with the EU's medicines regulator for its ...
FDA alerting vets about arthritis drug after hundreds of reports of health problems in dogs
The FDA is alerting veterinarians about reports of health problems in dogs, including hundreds of deaths, tied to a drug for ...
Sickle cell disease drug's withdrawal leads to suits against Pfizer
A once-groundbreaking sickle cell disease drug — at the center of a $5.4 billion acquisition two years ago — is the subject ...
European markets higher in shortened session ahead of Christmas; Novo Nordisk resumes recovery
Novo Nordisk resumed its rally on Tuesday, rising to the top of the Stoxx 600 during early deals and adding 5.7% by 11:05 a.m ...
AstraZeneca, Daiichi pull EU marketing application for lung cancer drug, Dato-DXd
AstraZeneca (AZN) and Daiichi Sankyo (DSNKY) withdraw EU marketing application for lung cancer therapy Dato-DXd. Read more ...
BioSpace7d
EMA to Investigate Eye Risk for Novo’s Ozempic: Reuters
Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have ...
PharmiWeb7d
Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib)
The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with and without an autologous stem cell transplant, followed by 24 months f ...
European agency endorses approval of Biocon Biologics’ biosimilar Ustekinumab
BENGALURU: Biocon Biologics, a biosimilars company and subsidiary of Biocon, has announced that the European Medicines Agency ...
Danish agency seeks probe as Ozempic study shows link to vision loss
The Danish Medicines Agency said it would ask European authorities to review two new studies that point to a link between ...
Anavex receives EMA filing acceptance for treatment of Alzheimer’s disease
Life Sciences announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorization Application, ...
Novo Nordisk's Ozempic faces EU review for potential eye disease connection
The European Union's drug regulator said it would assess two new Danish studies that link Novo Nordisk's popular diabetes ...