COVID-19 travel restrictions have hindered the FDA’s ability to inspect European manufacturing facilities for bimekizumab, which is under review for the treatment of patients with psoriasis.
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ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.
Most of the solutions have established systems to track patient outcomes over time, and several include performance guarantees as part of their solution.
This low-dose formulation of Biktarvy is for younger children living with HIV.
Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.
The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.
Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.
The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.
Boehringer Ingelheim will make Cyltezo available when its commercial license begins on July 1, 2023.
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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.
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.
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