February 6, 2026

FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system

​The US FDA has granted 510(k) clearance for Eyas Medical Imaging’ Ascent3T neonatal MRI system, a device engineered specifically for...

February 6, 2026

TransCode and Quantum Leap seek FDA approval for Phase IIa TTX-MC138 trial

​TransCode Therapeutics, in partnership with Quantum Leap Healthcare Collaborative, has submitted an IND application amendment seeking approval from the US...

February 6, 2026

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...

February 5, 2026

Hologic’s Aptima assay secures FDA approval for HPV primary screening

​Hologic has received FDA approval for its Aptima HPV assay for use in clinician-collected primary screening.The post Hologic’s Aptima assay...

February 5, 2026

Affinia receives FDA approval for Phase I/II trial for dilated cardiomyopathy

​Affinia Therapeutics has received approval from the US FDA for an IND application to initiate the UPBEAT Phase I/II trial...

February 5, 2026

PrimeGen US and DT Cloud Star sign $1.5bn merger agreement 

​PrimeGen US and DT Cloud Star Acquisition have entered a definitive merger agreement at an implied equity value of around...

February 4, 2026

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 post Endospan reports...

February 4, 2026

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, aimed at treating advanced solid tumours.The...

February 4, 2026

CEPI and Samsung Biologics partner to boost global vaccine preparedness

​CEPI and Samsung Biologics have partnered in an outbreak-ready vaccine manufacturing partnership to enhance the preparedness of global vaccine production...

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