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FDA approval
Pharma
Lack of global regulatory alignment spurs bad actors, FDA says
If a gene therapy is approved in the U.S., patients in Brazil can sue for access. It’s why global regulators need to work together, Peter Marks said.
Annalee Armstrong
May 9, 2024 10:15am
AZ, Daiichi's Enhertu cleared by FDA in wide range of tumors
Apr 8, 2024 10:49am
Teva, like Hikma, accuses Amarin of hoarding Vascepa ingredient
Mar 29, 2024 1:10pm
Italfarmaco wins FDA's blessing for nonsteroidal DMD therapy
Mar 22, 2024 11:05am
Orchard nabs approval for first MLD gene therapy in US
Mar 18, 2024 3:25pm
Novo's Wegovy scores key cardiovascular label expansion
Mar 8, 2024 3:51pm