Daiichi Sankyo announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy,… read more.
Astellas announced that the European Medicines Agency (EMA) has validated its Type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC… read more.
GSK plc announced that the FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential… read more.
Moderna, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Spikevax, its… read more.
Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS),… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for… read more.
AbbVie announced top-line results from the Phase III SEQUENCE clinical trial evaluating risankizumab (Skyrizi, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg… read more.
The FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult… read more.
Roche announced that the Phase III ALINA study evaluating Alecensa (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis…. read more.
Merck Inc., known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls… read more.
GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal… read more.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for bimekizumab (Bimzelx, UCB) for patients with active psoriatic arthritis and adult patients with active axial… read more.
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