FDA actions in Brief as reported June 1, 2002
UnitedHealth Group CEO Andrew Witty Defends PBMs
In an investor call, Andrew Witty promised full transparency and 100% pass-through rebates for prescription drugs by 2028.
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FDA Accepts BLA for Leqembi Autoinjector
If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025.
New FTC Report: PBMs Mark Up Specialty Generic Drugs
The Federal Trade Commission suggests that PBMs profit from specialty generic drugs such as those for cancer and HIV and steer patients to their own pharmacies.
FDA to Hold Ad Comm Meeting for Rexulti in PTSD
The target action date for Rexulti in combination with sertraline to treat patients with post-traumatic stress disorder, originally planned for Feb. 8, 2025, will be delayed.
Bayer Submits Supplemental NDA for Kerendia in Heart Failure
Kerenida is currently approved to slow the progression of chronic kidney disease associated with type 2 diabetes.
FDA Requires Guillain-Barré Warning for Abrysvo and Arexvy
Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus continue to outweigh their risks.
