The recall was related to syringes in these lots malfunctioning.
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Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.
The FDA has asked for an additional clinical trial with overall survival as the endpoint.
The new code will be effective April 1, 2022.
The study aims to generate data related to Tremfya in people of color who have plaque psoriasis.
The recall of orphenadrine was due to the presence of the cancer-causing nitrosomine.
Cystaran is a topical ophthalmic therapy that is used to treat a rare genetic disorder.
The CRL delays the commercial return in the United States, Takeda didn’t release any information about the reason for the CRL.
The recall of Accuretic and generics distributed by Greenstone is a result of the presence of a cancer-causing agent.
The FDA also approved a companion diagnostic to select patients with mismatch repair deficiency who would be eligible for treatment with Keytruda.
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But there is no significant difference in rate of hospitalization for major bleeding when Eliquis is compared with Xarelto or warfarin.
Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.
Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.
Ztalmy was approved for seizures associated with CDKL5 deficiency disorder in patients two years of age and older. It is expected to be available in July 2022.
Del Doherty, co-founder of Prodigy Rx, discusses how the PBM aims to give payers control so they can lower costs and can improve clinical and return-to-work outcomes.
Amneal is of 35 global companies selected to manufacture and commercialize generic version of COVID-19 treatment Paxlovid.
New data show longer-term benefits from Aduhelm, which was approved last year to treat Alzheimer’s disease.
ICER analyzed two therapies — Cosela and plinabulin — to prevent chemotherapy-induced neutropenia and other myelosuppressive effects. Both moderately increased quality-adjusted life-years.
This approval is the first indication for Rinvoq in gastroenterology.
Allan Coukell, Civica’s senior vice president of public policy, discusses how the generic manufacturer is disrupting the market for insulins.
Evio Pharmacy Solutions plans to provide biosimilar alternatives for autoimmune and cancer therapeutics.
Called Breyna, this drug-device combination generic product is a metered-dose inhaler, which contains both budesonide and formoterol.
In an interim analysis, Keytruda/Lynparza did not improve overall survival in patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy.
After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.
The FDA has asked for clinical data for Fasenra, which is being reviewed as a treatment for chronic rhinosinusitis with nasal polyps.
Adlarity delivers donepezil to patients using a skin patch, lowering the risk of gastrointestinal adverse events. It will be available in early fall 2022.
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