资讯

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes
The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a ...
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday.
Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug
The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after ...
STAT2 小时Opinion
A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry
More than 50 biotech leaders and investors are urging the FDA to disregard a methodologically flawed report on mifepristone.
FDA approves Juul's tobacco and menthol e-cigarettes
The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in ...
US FDA advisers vote against Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...
GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
Food Business News1 天
FDA targets 52 food standards of identity for termination
WASHINGTON — The US Food and Drug Administration aims to revoke 52 standards of identity (SOI) across a swath of food ...
FDA approves Juul e-cigarette and cartridge sales
Officials with the Food and Drug Administration have approved the continued sales of tobacco-flavored e-cigarettes and refill ...
Dairy Reporter1 天
FDA to scrap ‘obsolete’ food standards to boost transparency
The FDA proposes to revoke standards for 18 dairy products, including low-sodium cheddar and colby cheese, acidified milk and ...
FDA approves new blue food dye derived from gardenia fruit
The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering ...