The FDA was expected to make its decision by Wednesday, but it is still reviewing Liquidia’s marketing application for possible approval, although it has not asked for any additional clinical data to support the application.
Tag Archive for: FDA
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
At the beginning of January, the FDA announced that it was authorizing Florida’s Agency for Health Care Administration to import certain prescription drugs from Canada. Leslie Isenegger, practice leader, corporate pricing and public affairs at Real Chemistry, answers some key questions about the implications the program could have on the pharma industry.
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
The agency stated that companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others.
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly (LLY.N) plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters.
A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period.
The FDA’s decision further pushes the timeline for Shin Nippon to enter a crowded U.S. market for migraine drugs that include treatments from Pfizer, Abbvie, and Eli Lilly.
