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The FDA's draft guidance on gene-edited therapies describes how multiple product variants can be included in a single BLA ...
The Oct. 30 advisory committee meeting will weigh the FDA’s concerns about the “fragility” of Sydnexis’ data for low-dose ...
‘Synchronized Swimming’ Must Wait, But FDA And EMA Ready To Collaborate On Botanical Drug Regulation
FDA and EMA say they could start collaboration on herbal and botanical drug regulation with batch-to-batch quality variation ...
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 ...
Alzheimer’s blood testing is moving into primary care clinics faster than clear guidance for how to integrate the tests. Four ...
Tumaini, an adaptive platform trial of vaccine candidates for Bundibugyo ebolavirus, has begun with MSD’s Ervebo, with ...
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” ...
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