Sobi has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) for treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have… read more.
Medtronic announced it received approval from the National Medical Products Administration (NMPA) in China for its Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood… read more.
Edwards Lifesciences announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company’s breakthrough RESILIA tissue technology, designed… read more.
Eyenovia announced results from a Phase IV study of Mydcombi designed to characterize the lowest deliverable dose for mydriasis (pupil dilation). Mydcombi is the only FDA-approved fixed dose… read more.
Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III KEYNOTE-811 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with… read more.
FRAIL-AF trial investigators set out to study the question of whether frail, elderly patients with atrial fibrillation who were doing well with vitamin K antagonists (VKA) should be… read more.
Aurinia Pharmaceuticals Inc. announced that the FDA has approved a label update for Lupkynis. The updated label no longer includes language indicating that the safety and efficacy of… read more.
ImmunityBio, Inc. an immunotherapy company, announced that the FDA has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive… read more.
Gilead Sciences, Inc. announced the FDA approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25… read more.
Medtronic plc announced that the FDA has approved the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS… read more.
AbbVie announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase IIIb/IV study that evaluated the efficacy and safety of upadacitinib (Rinvoq, 15 mg once… read more.
On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for… read more.
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