FDA grants BDD for Roche’s Elecsys GDF-15 assay addressing cancer weight loss
Roche has revealed that their assay Elecsys® GDF-15 assay has been approved as a companion diagnostic (CDx) in cancer therapy
Read more
Regulatory
CABENUVA approved by the FDA as first long-acting HIV regimen
The U.S FDA has given the green light to Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for
Read more
EC and UK authorise Moderna’s RNA-based COVID-19 Vaccine
The EC and UK have granted authorisation for the use of the Moderna COVID-19 Vaccine in individuals 18 years of
Read more
UK approves AstraZeneca and Oxford University COVID-19 vaccine
Drug regulators in the United Kingdom have approved a second COVID-19 vaccine for emergency use today, for the active immunisation
Read more
European Union starts COVID-19 vaccination program
European Union nations, including France, Germany, Italy, Austria, the Czech Republic, Bulgaria, Greece, Latvia, Portugal and Spain have commenced mass
Read more
Moderna’s COVID-19 vaccine approved by the FDA for emergency use
The U.S. FDA has approved Moderna’s COVID-19 vaccine for emergency use. Moderna’s vaccine becomes the second to be approved by
Read more
US FDA clears Pfizer-BioNTech COVID-19 Vaccine for emergency use
The United States FDA has approved the emergency use of Pfizer and BioNTech’s COVID-19 vaccine on Friday, paving the way
Read more
UK approves Pfizer and BioNTech’s COVID-19 vaccine for emergency use
The UK has become the first western country to approve Pfizer and BioNTech’s COVID-19 vaccine for emergency use. The United
Read more
FDA approves Roche’s Xofluza for Influenza post-exposure prophylaxis
Roche has announced that the U.S. FDA has granted supplemental New Drug Application (sNDA) approval for Xofluza, the first single-dose
Read more
EC approves GSK’s Zejula for advanced ovarian cancer treatment
Zejula (niraparib), developed by pharma giant GSK, has become the first polymerase (PARP) inhibitor approved as monotherapy in the EU for
Read more