FDA
Seagen’s Adcetris has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.
The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.
Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.
Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
The FDA recommended additional clinical and statistical data analyses of Vicineum, as well as issues related to the company’s Chemistry, Manufacturing, and Controls.
This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
Merck’s Welireg won FDA approval for adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system, and hemangioblastomas.
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
Palovarotene is being developed for the prevention of heterotropic ossification, which is new bone formation in people with fibrodysplasia ossificans progressive.