Keyword: Food and Drug Administration (FDA)
Verily has received a 510(k) clearance from the FDA for its own clinical study smartwatch, complete with an on-demand ECG.
CMO Sean Bohen and I-O head David Berman are leaving AstraZeneca, while Roche's Omar Khwaja and Pearl Huang land at new biotechs.
The FDA plans to hire at least 50 reviewers for cell and gene therapies ahead of what it describes as a surge of products entering development.
Aimmune has confirmed that the government shutdown will delay the FDA’s review of AR101, its oral immunotherapy for peanut allergy.
Abbott received FDA approval for its Amplatzer Piccolo Occluder, which it describes as the world’s first implant for babies as little as two pounds.
The FDA cleared Ossio’s family of bio-integrative bone pins, which secure broken bones while leaving no permanent hardware behind.
Gottlieb said the work is needed to prevent threats during “one of the most significant operational challenges” in the recent history of the agency.
The FDA shutdown is holding up human trials for Aimmune's egg allergy program and may delay approval for its oral immunotherapy for peanut allergy.
A cancer vaccine being developed by Epitopoietic Research Corp. has become the first drug to be given to a U.S. patient under new "right-to-try" legislation.
Staff at the office will create tools that sponsors and the FDA can use to streamline the development and regulatory assessment of drugs.