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FDA approval for Myhibbin (mycophenolate mofetil oral suspension) to protect a donated organ from being rejected from the body’s immune response – Azurity Pharma

Written by | 14 May 2024

Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced that the FDA has approved… read more.

UCB presents final open-label extension (fenfluramine) data at International Child Neurology Congress (ICNC) Annual Meeting

Written by | 13 May 2024

UCB announced the final three-year open-label extension (OLE) study results of Fintepla (fenfluramine) in Dravet syndrome are being presented at the International Child Neurology Congress (ICNC), May 6-10,… read more.

NMPA (China) approves Symplicity Spyral renal denervation (RDN) system – Medtronic

Written by | 12 May 2024

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.

Launch of Sapien 3 Ultra RESILIA valve in Europe with technology to enhance durability – Edwards Lifesciences

Written by | 11 May 2024

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.

Results from phase IV study of Mydcombi (phenylephrine + tropicamide) to characterize the lowest deliverable dose for mydriasis – Eyenovia

Written by | 10 May 2024

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.

Phase III KEYNOTE-811 trial met dual primary endpoint of overall survival as first-line treatment in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma – Merck

Written by | 9 May 2024

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.

Safety of switching from a Vitamin K antagonist to a non–Vitamin K antagonist oral anticoagulant in frail older patients with atrial fibrillation

Written by | 8 May 2024

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.

FDA approves updated Lupkynis (voclosporin) label to include long term data from the Aurora Clinical Program – Aurinia Pharmaceuticals

Written by | 7 May 2024

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.

FDA approves Anktiva, (N-803, or nogapendekin alfa inbakicept-pmln) first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer – ImmunityBio

Written by | 6 May 2024

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.

FDA approves Biktarvy label update with data for pregnant adults with HIV – Gilead Sciences

Written by | 5 May 2024

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.

FDA approval for Inceptiv closed-loop spinal cord stimulator for the treatment of chronic pain – Medtronic

Written by | 4 May 2024

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.

New data show Rinvoq (upadacitinib) demonstrated superiority versus Dupixent (dupilumab) across primary and all secondary endpoints in an open-label head-to-head atopic dermatitis study – Abbvie

Written by | 3 May 2024

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.

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