Leqvio (inclisiran), became the first siRNA therapy for dyslipidemia approved in Japan. The drug was approved for familial and non-familial hypercholesterolemia and is intended for patients who are… read more.
On 14 September 2023, 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.
Novartis announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials. The data demonstrated that with twice-yearly dosing (after an… read more.
On 26 May 2023, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revoking the conditional marketing authorization (MA) for crizanlizumab. On 3… read more.
The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Novartis’ Luxturna (voretigene neparvovec) for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations. The… read more.
Novartis announced that it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued… read more.
Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to… read more.
Novartis presents positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting . Data showed that… read more.
Novartis is pleased to announce that eligible patients in England and Wales will soon have routine access to Adakveo (crizanlizumab) under a Managed Access Agreement (MAA). The news… read more.
Novartis welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination recommending Rydapt (midostaurin) for the treatment of aggressive… read more.
Novartis announced that Entresto (sacubitril/valsartan) has received a new indication in China for the treatment of patients with essential hypertension, a disease affecting approximately 245 million adults in… read more.
Genentech, a member of the Roche Group announced that the FDA has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all… read more.
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