The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung… read more.
Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch… read more.
Pfizer Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe… read more.
On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Sun Pharmaceutical Industry announced that the FDA approved Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. Alopecia areata affects around 700,000 people… read more.
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.
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