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 ...
FDA cites Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection...
The Trump administration considers an executive order addressing vaccines and autism as soon as next week.
Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) introduce the bipartisan Prescription Information Modernization Act to allow drug makers to distrib...
FDA calls on small drug dispensers with no more than 25 employees to complete an assessment so the agency can evaluate the dispensers ability to condu...
Eight House Democrats ask FDA acting commissioner Kyle Diamantas what the agency is doing and can do to ease a growing shortage of estrogen patches us...
FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.
