GSK plc announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has shared 48-week findings from the PASO… read more.
Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva (ustekinumab) across Europe. Pyzchiva, developed and registered by Samsung Bioepis, is the first ustekinumab… read more.
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking approval of Spravato (esketamine) CIII nasal spray as a monotherapy for… read more.
The addition of durvalumab (Imfinzi) to gemcitabine and cisplatin demonstrated a sustained overall survival (OS) benefit vs chemotherapy alone in patients with unresectable, locally advanced or metastatic biliary… read more.
Zai Lab Limited and argenx announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg… read more.
Sobi announced the publication of full results from the Phase III XTEND-Kids study in The New England Journal of Medicine (NEJM) confirming the safety and efficacy profile of… read more.
Roche announced four-year data from the RHONE-X extension study. The study met all primary endpoints, showing that Vabysmo (faricimab) was well tolerated in people with diabetic macular edema… read more.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Roche’s subcutaneous version of Ocrevus (ocrelizumab subcutaneous ) to treat patients with relapsing and primary progressive… read more.
The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.( radiological progression-free survival). Darolutamide… read more.
Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of… read more.
Novo Nordisk announced that the FDA has issued a Complete Response Letter covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus…. read more.
Idorsia Ltd announced that the European Commission (EC) has approved Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive… read more.
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