Showing 1672 results
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Ad hoc release /The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related…
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Press release /There are no currently approved therapies impacting disease progression for the up to 8 million people suffering from geographic atrophy (GA)1,2 Acquisition will add GT005 to the Novartis portfolio…
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Press release /Farydak (panobinostat) combination improved PFS by 7.8 months for patients who received >=2 prior regimens including bortezomib and an IMiD[1] Farydak would be the first HDAC inhibitor with…
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Press release /European Medicines Agency validated MAAs for tislelizumab in multiple non-small cell lung cancer and esophageal squamous cell carcinoma indicationsSubmissions based on data from Phase III RATIONALE…
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Press release /New Cosentyx® (secukinumab) label to include dosing flexibility up to 300 mg, based on clinical response, and 24-week structural data with subcutaneous (sc) regimens[1] Cosentyx inhibits…
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Press release /Dear SMA Community, Since its U.S. approval, AveXis has had increasing demand from families outside of the U.S. for access to AVXS-101. While we are pursuing registration in close to three dozen…
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Press release /Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using their own T cells Novartis made an early commitment to the…
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Press release /Priority Review based on Phase III MONALEESA-2 trial, which showed LEE011 plus letrozole, as initial treatment for advanced breast cancer, significantly extended progression-free survival compared…
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Press release /Exclusive license for emricasan supports rapidly growing development portfolio in chronic liver diseases, including NASH Conatus has initiated the Phase IIb ENCORE-LF clinical trial with…
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Press release /5 year data from long-term Phase III extension study demonstrate sustained efficacy and safety of Cosentyx in patients with moderate-to-severe plaque psoriasis[1] Data planned to be…