News BridgeBio gets EU nod for ATTR cardiomyopathy drug BridgeBio and Bayer are poised to challenge Pfizer's Vyndaqel in the EU after acoramidis gets a green light for ATTR cardiomyopathy.
News FDA clears new antibiotic for superbug infections AbbVie has won FDA approval for Emblaveo, a new antibiotic to treat pathogens that pose serious public health threats.
News FDA expands label for Roche's eye disease implant Susvimo The renaissance of Roche's refillable ophthalmic implant Susvimo has continued with FDA approval for use in patients with diabetic macular oedema.
News Boost to Enhertu's prospects as FDA clears Roche diagnostic Roche gets the first FDA approval for a diagnostic test for HER2-ultralow breast cancer, now on the label of AstraZeneca and Daiichi Sankyo's Enhertu.
News Vertex bags FDA okay for its non-opioid pain drug Vertex gets FDA approval for its non-opioid pain drug suzetrigine, the first new class of pain medicine in the US in more than 20 years.
News Ozempic is first GLP-1 drug FDA-approved for kidney disease Novo Nordisk's Ozempic has become the first drug in the GLP-1 class to be cleared to prevent worsening kidney disease in type 2 diabetics.
News Are Makary's priority review vouchers about to be canned? Reports are emerging that the national priority voucher scheme launched by former FDA chief Marty Makary may be heading for the scrap heap.
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