GE HealthCare is buying SOFIE Biosciences to take direct control of Flyrcado’s final-mile distribution, as the company bets ...
The FDA's draft guidance on gene-edited therapies describes how multiple product variants can be included in a single BLA ...
HHS, not the FDA, issued the enforcement discretion policy, which is unusual and suggests a split between the department and ...
The US Food and Drug Administration posted warning letters to three medical device manufacturers on Oct. 27, citing ...
The Oct. 30 advisory committee meeting will weigh the FDA’s concerns about the “fragility” of Sydnexis’ data for low-dose ...
Alzheimer’s blood testing is moving into primary care clinics faster than clear guidance for how to integrate the tests. Four ...
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in ...
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it ...
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in ...
NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” ...
Efficacy among previously treated HR+/HER2- breast cancer patients looked in line with Merck/Kelun’s sac-TMT, but an analyst ...
The UK wants to change the way medtech companies interact with its medical regulator via a more transparent process and ...
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