EMA grants orphan medicinal product designation to Applied’s AT-007
AT-007 also received Fast Track designation from the US FDA to treat Galactosemia.

AT-007 also received Fast Track designation from the US FDA to treat Galactosemia.
Corbevax will be given after six months of the first two doses of either Covaxin or Covishield vaccines.
Pharmaceutical Technology does a roundup of regulatory decisions in recent months that impact drugs and the CMOs enlisted to manufacture…
ByThe latest approval is based on interim data from the RAINBOWFISH trial of Evrysdi in pre-symptomatic babies.
Two 50μg doses of the vaccine showed to stimulate a robust immune response for children aged six to 11 years.
The FDA approved Kymriah based on findings from the Phase II ELARA trial of the cell therapy in FL patients.
In a study in England, girls aged 12 to 13 years who received the vaccine doses had an 87% decline…
The CMA is supported by the open-label, multi-centre Phase Ib/II CARTITUDE-1 clinical trial of cilta-cel to treat RRMM.
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