Alvotech advances dual Entyvio biosimilar strategy as FDA accepts subcutaneous AVT80 application
FDA accepts Alvotech’s AVT80 application for a subcutaneous Entyvio biosimilar, expanding its vedolizumab strategy alongside Teva.
Pharma & Biotech
Pharma & Biotech
CAD-1005 moves toward Phase 3 as FDA backs thrombotic endpoint strategy in heparin-induced thrombocytopenia
Cadrenal Therapeutics gains FDA alignment on a Phase 3 CAD-1005 trial in HIT after encouraging thrombosis data. See the risks and next steps.
Pharma & Biotech
QTORIN reaches FDA after positive Phase 3 results as Palvella Therapeutics prepares 2027 launch
Palvella Therapeutics completes its QTORIN FDA submission after positive Phase 3 results, moving a potential first microcystic LM therapy closer to approval.
Features & Analysis
Could AI find hidden heart attack risk inside a routine coronary CT scan?
FDA-authorized CaRi-Heart software analyzes inflammation in the fat surrounding coronary arteries and combines it with clinical information to estimate cardiovascular mortality risk, pointing toward a future where routine CT scans reveal biological danger invisible to conventional measurements of artery narrowing.
Medical Devices & Diagnostics
FDA grants De Novo authorization to Brixton Biosciences’ ReneuRx nerve-selective pain device
FDA records show a De Novo grant for Brixton Biosciences’ ReneuRx, also known as Neural Ice, a nerve-selective technology developed as a drug-free injectable approach to longer-lasting knee osteoarthritis pain control.
Medical Devices & Diagnostics
FDA warns on Abiomed Impella controllers after 37 serious injuries and three deaths
The FDA has issued an early alert involving Abiomed Automated Impella Controllers after purge-cassette recognition failures were associated with 37 serious injuries and three deaths, prompting replacement of controller components used with life-sustaining heart pumps.
Pharma & Biotech
Bristol Myers Squibb and Johnson & Johnson’s milvexian fails 14,194-patient Phase 3 heart attack trial
Milvexian failed to reduce cardiovascular death, heart attack or ischemic stroke after acute coronary syndrome in the Phase 3 LIBREXIA ACS trial, although the drug did not increase intracranial or fatal bleeding, leaving two major Phase 3 programs to determine whether factor XIa inhibition still works in other diseases.
Pharma & Biotech
Statins cut major cardiovascular events by 30% in healthy adults over 70, STAREE trial finds
The landmark STAREE randomized trial found that atorvastatin reduced first major cardiovascular events by 30% among adults aged 70 and older without established cardiovascular disease, diabetes or dementia, potentially resolving a long-running treatment question for older patients.
Features & Analysis
Claude can now operate microscopes, liquid handlers and robot arms. What happens when AI leaves the chatbot?
Anthropic’s new Model Hardware Standard allows artificial-intelligence agents to control microscopes, liquid handlers, robotic arms and other physical laboratory equipment, creating a path toward autonomous drug-discovery laboratories capable of designing, running and adjusting experiments around the clock.
Medical Devices & Diagnostics
FDA flags Boston Scientific Imager II catheter risk as company removes product from market
Boston Scientific is removing all Imager II angiographic catheters from use after discovering that reduced stabilizing agents in catheter tips could increase degradation and detachment risk, while the medtech company simultaneously works through a separate global cyber disruption.