Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Piqray (alpelisib) in… read more.
Myovant Sciences announced additional results from its Phase III HERO study of once-daily, oral TAK 385 (relugolix) (120 mg) in men with advanced prostate cancer in an oral… read more.
Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.
Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.
Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.
Remdesivir has been granted a special early access status in the UK, which will allow patients hospitalized with COVID-19 to receive the antiviral treatment.The public assessment report issued… read more.
Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.
Genentech, a member of the Roche Group announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra… read more.
Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by… read more.
Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the ongoing EMA review of imlifidase for a potential marketing authorization in Europe… read more.
Aurinia Pharmaceuticals Inc.has announced the completion of the rolling submission of a New Drug Application (“NDA”) to the FDA for voclosporin as a potential treatment for lupus nephritis… read more.
Novartis announced that new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European… read more.
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