The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.
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Boehringer Ingelheim will make Cyltezo available when its commercial license begins on July 1, 2023.
The committee’s two-day meeting resulted in recommended approvals for both J&J’s and Moderna’s COVID-19 booster.
Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.
This is the second specialty pharmacy selected to distribute Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.
The FDA has assigned a target action date of April 13, 2022, and plans to hold an advisory committee meeting.
The committee voted unanimously to support the booster given at least six months after the second dose in the original vaccine.
The product contained N-nitrosoirbesartan impurity, a probable human carcinogen.
This is the first anti-PD-1 combination approved for patients with persistent, recurrent or metastatic cervical cancer.
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Hikma, which makes the broad-spectrum antibiotic, has experienced manufacturing delays.
The FDA has approved Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.
Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.
Drugs with accelerated approval represent a larger amount of Medicaid drug spending relative to their use.
Compared with Keytruda, Libtayo resulted in an incremental gain of 3.44 life-years and incremental cost-effectiveness ratio of $130,329 per quality-adjusted life-year.
The company has received a PDUFA action date of March 11, 2022, for Adlarity, a transdermal patch for the treatment of Alzheimer’s disease.
Inserts replace steroid eyedrops.
Genentech is conducting phase 3 trials of gantenerumab, an anti-amyloid antibody.
Molnupiravir reduced the risk of hospitalization or death by about 50%.
The announcement was made by Pfizer and BioNTech on Twitter
An FDA decision is expected in late 2022.
If approved, maribavir would be the first therapy to treat transplant patients with cytomegalovirus.
Investigators found only small differences in the change in LDL-C levels in the incentive groups versus the control group
Gavreto treats patients with advanced lung care and Arcalyst treats patients with recurrent pericarditis.
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