Neurocrine Biosciences, Inc. presented new data from the long-term, open-label KINECT 4 study demonstrating remission of tardive dyskinesia among the majority of patients treated with once-daily Ingrezza (valbenazine) capsules…. read more.
NICE (UK): 12 standard quality house dust mite sublingual lyophilisate (SQ-HDM SLIT) is recommended, within its marketing authorisation, as an option for treating moderate to severe house dust mite… read more.
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced new data from two implementation studies showing zero cases of… read more.
Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Lunsumio for intravenous infusion 1mg” and “Lunsumio… read more.
AbbVie announced the final analysis of the confirmatory Phase III MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive… read more.
Eli Lilly announced results from the Phase III BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor in adult patients with chronic lymphocytic leukemia or… read more.
Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase III BREAKWATER study of Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6… read more.
Regeneron Pharmaceuticals, Inc. announced positive results from the Phase III C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo (cemiplimab) led to a statistically significant and… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Calquence…. read more.
The FDA has approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) from Sanofi for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus…. read more.
Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application and accepted to start the review of the… read more.
GSK plc announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with… read more.
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