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Regulatory update on sBLA for four-dose Heplisav-B regimen for adults on hemodialysis in the US – Dynavax Technologies

Written by | 19 May 2024

Dynavax Technologies Corporation provided a regulatory update for the Company’s supplemental Biologics License Application (sBLA) to include a four-dose Heplisav- B vaccine [Hepatitis B Vaccine (Recombinant),Adjuvanted] regimen for… read more.

Four year data for Wegovy (semaglutide) in obesity presented at ECO meeting and published in Nature – Novo Nordisk

Written by | 18 May 2024

At the European Congress on Obesity in Venice, investigators unveiled results from an analysis published in Nature Medicine evaluating Wegovy’s weight loss benefits over four years. With this… read more.

Phase III CheckMate-73L trial did not meet its primary endpoint in stage III non-small cell lung cancer – BMS

Written by | 17 May 2024

Bristol Myers Squibb announced the Phase III CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell… read more.

National approvals in all EU countries for MOB 15 to treat mild to moderate fungal infections of the nails – Moberg Pharma

Written by | 16 May 2024

Moberg Pharma AB hereby announces that MOB 015 has received national approvals for all countries included in the decentralized procedure. MOB 015 is thus approved for the treatment… read more.

Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH – Sobi

Written by | 15 May 2024

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.

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.

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