The FDA's draft guidance on gene-edited therapies describes how multiple product variants can be included in a single BLA ...
GE HealthCare is buying SOFIE Biosciences to take direct control of Flyrcado’s final-mile distribution, as the company bets ...
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 ...
‘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 ...
Nanexa’s CEO said PharmaShell’s ALD-coated particles could stretch GLP-1 dosing to monthly or quarterly, but its semaglutide ...
In the wake of ambitious new long-term strategic targets revealed by Sandoz, the firm’s chief financial officer Remco ...
Major global CDMO Samsung Biologics and labor union set to open new new talks designed to resolve pay dispute.
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 ...
Biobeat says interim data from its 600-patient trial support its FDA-cleared chest patch as a more comfortable alternative to ...
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