June 12, 2026

FDA grants priority review for Roche’s Tecentriq combo sBLA

​Roche has received the FDA priority review for its sBLA for adjuvant Tecentriq and Tecentriq Hybreza in combination with chemotherapy...

June 11, 2026

Sibel Health’s ANNE One platform secures EU MDR CE mark

​Sibel Health has received CE mark certification under the EU MDR for its ANNE One system, designating it as a...

June 11, 2026

CONNECTA Therapeutics begins Phase IIa trial of CTH120 for FXS

​CONNECTA Therapeutics has started a Phase IIa trial to assess CTH120, a neuroplasticity modulator, in adult males with fragile X...

June 11, 2026

EMA validates Bayer’s asundexian application for ischaemic stroke

​The EMA has validated Bayer's marketing authorisation application for asundexian, an oral Factor XIa inhibitor, to prevent ischaemic stroke.The post...

June 10, 2026

MHRA to roll out new AI sandbox for medicines development 

​The UK’s MHRA has announced plans to launch a new AI sandbox to expedite the development of medicines and improve...

June 10, 2026

Windward Bio doses first patients in Phase II SIRIUS COPD trial

​Harbour BioMed’s partner Windward Bio has dosed the first patients in the Phase II SIRIUS trial with SKB378 to treat...

June 10, 2026

Gore secures CE Mark for venous stent to treat inferior vena cava

​Gore has secured CE Mark approval under the MDR for its Gore Viabahn Fortegra venous stent to treat symptomatic IVC...

June 9, 2026

Medtronic secures CE mark for Stealth AXiS system for ENT surgery

​Medtronic has received the CE mark for its Stealth AXiS surgical system, clearing the way for its use in ENT...

June 9, 2026

Coya Therapeutics begins extension phase of ALSTARS trial for COYA 302

​Coya Therapeutics has begun the blinded extension phase of the ALSTARS trial, evaluating the safety and efficacy of COYA 302...

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