BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing
A BridgeBio Pharma drug developed for dwarfism elevated youngsters’s progress charges in a pivotal medical trial, assembly the research’s fundamental ...
Tag: FDA
FDA refuses to review Moderna’s flu vaccine application
Helen Branswell covers points broadly associated to infectious ailments, together with outbreaks, preparedness, analysis, and vaccine growth. Observe her on ...
New Mexico warns raw milk linked to infant death, while FDA announces new testing of baby formula
Officers in New Mexico are warning state residents to keep away from consuming uncooked dairy merchandise following the dying of ...
STAT+: AI doctors are coming. Should FDA make sure they’re safe?
When is an AI physician a medical gadget? Name it an indication of issues to return. A startup referred to as ...
Presbyopia Eye Drop From Startup Tenpoint Gets FDA Approval, Paving Way for $235M Financing
The gradual lack of close to imaginative and prescient that could be a pure a part of getting older might ...
French Startup Gains FDA Clearance for First In‑Ear EEG Device
French medtech startup Naox Applied sciences this month grew to become the primary firm to obtain FDA 510(ok) clearance for ...
FDA needs sharper focus on foodborne-illness prevention, accountability office says
A Government Accountability Office (GAO) report released yesterday finds that while the US Food and Drug Administration (FDA) has made strides ...
FDA relaxes oversight of AI-enabled devices and wearables
Food and Drug Administration Commissioner Marty Makary.ANDREW CABALLERO-REYNOLDS/AFP via Getty Images Lizzy Lawrence leads STAT’s coverage of the Food and ...
Cytokinetics heart drug wins FDA approval, the biotech’s first
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and ...
FDA approves Nuzolvence, new pill for gonorrhea
A new kind of oral antibiotic to treat gonorrhea has secured Food and Drug Administration approval, the second time in ...
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