Healthcare in 2022: what you need to know
With the Covid-19 pandemic sending shockwaves in the hospital sector, healthcare providers will continue looking for ways to slowly rebuild …
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FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Eyas Medical Imaging’s Ascent³ᵀ neonatal magnetic resonance imaging …
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TransCode and Quantum Leap seek FDA approval for Phase IIa TTX-MC138 trial
A partnership comprising TransCode Therapeutics and Quantum Leap Healthcare Collaborative has submitted an investigational new drug (IND) application amendment seeking …
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Apotex and Grünenthal sign deal for Nebido Canadian distribution
Apotex and Grünenthal have finalised a licensing agreement granting Apotex exclusive Canadian rights to Nebido, a long-acting injectable testosterone undecanoate …
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Hologic’s Aptima assay secures FDA approval for HPV primary screening
Hologic has received the US Food and Drug Administration (FDA) approval for its Aptima HPV assay for use in clinician-collected …
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Affinia receives FDA approval for Phase I/II trial for dilated cardiomyopathy
Affinia Therapeutics has received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application …
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Healthcare in 2022: what you need to know
With the Covid-19 pandemic sending shockwaves in the hospital sector, healthcare providers will continue looking for ways to slowly rebuild …
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PrimeGen US and DT Cloud Star sign $1.5bn merger agreement
PrimeGen US and DT Cloud Star Acquisition have entered a definitive business combination agreement at an implied equity value of …
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Endospan reports one-year TRIOMPHE study results for NEXUS system
Endospan has announced positive one-year results from the TRIOMPHE study evaluating its NEXUS aortic arch stent-graft system. The multi-centre, three-arm, prospective …
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Biosion doses first patient in Phase Ia/Ib BSI-082 trial for solid tumours
Biosion has dosed the first patient in an investigator-initiated Phase Ia/Ib trial of BSI-082, a fully human anti-SIRPα monoclonal antibody, …
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CEPI and Samsung Biologics partner to boost global vaccine preparedness
The Coalition for Epidemic Preparedness Innovations (CEPI) and Samsung Biologics have partnered in an outbreak-ready vaccine manufacturing partnership to enhance …
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Medtronic achieves three milestones for MiniMed 780G system in US
Medtronic has reported three milestones in the US, expanding access to its MiniMed 780G insulin delivery system for individuals with …
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Arcutis reports positive topline data in Zoryve trial for infant AD
Arcutis has reported positive topline data from the INTEGUMENT-INFANT Phase II trialassessing Zoryve (roflumilast) cream 0.05% in infants aged three …
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Aquestive receives FDA CRL for Anaphylm allergic reaction treatment
Aquestive Therapeutics has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new …
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ALX Oncology announces Phase Ib/II trial results for breast cancer
ALX Oncology has announced new data from a Phase Ib/II clinical trial of its cluster of differentiation 47 (CD47)-inhibitor, evorpacept, …
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Cynosure Lutronic secures CE Mark for Mosaic 3D platform
Cynosure Lutronic has announced CE Mark approval under the European Medical Device Regulation (MDR) for its Mosaic 3D fractional resurfacing …
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CIRM unveils RAPID funding programme for rare diseases
The California Institute for Regenerative Medicine (CIRM) in the US has approved the Rare Disease Acceleration Platform and Innovation and …
