FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and its use in the early detection of multiple cancers.
Primus petitions FDA to address substantive issues about generic forms of its Impoyz psoriasis drug that were first raised by Encore Dermatology when it held the Impoyz NDA but were not answered by the agency.
FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and its use in the early detection of multiple cancers.
Primus petitions FDA to address substantive issues about generic forms of its Impoyz psoriasis drug that were first raised by Encore Dermatology when it held the Impoyz NDA but were not answered by the agency.
FDA cites Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection conducted in May.
The Trump administration considers an executive order addressing vaccines and autism as soon as next week.
