Illuccix is approved to detect prostate cancer when using PET scan. It is available through Cardinal Health, PharmaLogic, and United Pharmacy Partners.
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A phase 3 trial is expected to begin by the end of the second quarter.
The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.
Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.
Camcevi is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required.
The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.
The FDA’s final decision on AMX0035 is expected by June 29, 2022
The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.
AllianceRx Walgreens Prime study has found that patients taking Ocaliva may not be adherent to their treatment regimen for rare liver disease.
A disconnect exists between payers and patients with rare diseases about including patient input in the formulary process for orphan drugs.
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The FDA is asking for nearly a 34% increase over the agency's fiscal year 2022 funding level.
The long-acting HIV medication is now available for those 12 years and older living with HIV-1.
Antares Pharma plans to launch Tlando, which doesn’t require dose titration, in the second quarter of 2022.
The FDA determined that the benefits of the second booster dose outweighed the risks after reviewing data from Pfizer, BioNTech, and Moderna.
Ozempic is now available in three doses to improve blood sugar in people with type 2 diabetes.
Prior authorization and step therapy can impact compliance and outcomes, according to a survey by the Pharmaceutical Research and Manufacturers of America.
The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.
Xipere is a targeted treatment that is delivered via an injection to the back of the eye to treat macular edema associated with uveitis, a form of eye inflammation.
Fintepla was approved to treat Lennox-Gastaut syndrome, which first appears in childhood and can affect neurodevelopmental, cognitive, and motor functions.
This real-world study found that patients who received Relistor SC during an emergency department visit for opioid induced constipation had lower costs and hospital lengths of stay.
Some generics have as much of a 10,000-times increase from the manufacturers weighted average manufacturers price to what a patient could pay at the pharmacy if they chose to pay the cash price.
Reblozyl is being reviewed to treat anemia in patients with beta thalassemia. The new date is June 27, 2022.
The recall was related to syringes in these lots malfunctioning.
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.
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