European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. Pluvicto is an intravenous radioligand therapy that combines a ligand, a targeting compound with lutetium-177, a therapeutic radionuclide.

Chemotherapy 93

Chemotherapy Compounding Labelling FDA 93

pharmaphorum

DECEMBER 5, 2022

Pluvicto becomes the first PSMA-targeted intravenous radioligand therapy – combining a targeting compound or ligand with a therapeutic radionuclide or radioactive particle (in this case, lutetium-177) – to demonstrate clinical benefit in mCRPC patients before receiving taxane-based chemotherapy.

Chemotherapy 59

Chemotherapy Compounding Labelling FDA 59

pharmaphorum

APRIL 20, 2021

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings. . Both have been granted an FDA priority review with an action date of 17 August.

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Chemotherapy FDA Compounding Labelling 52

The Checkup by Singlecare

MARCH 28, 2024

For this reason, its use in dogs is off-label. Veterinarians may use it in a cat to prevent nausea and vomiting due to chemotherapy. So, read labels carefully. Pet parents will use tablets made for humans or mirtazapine custom-made by a compounding pharmacy. Its use as an antiemetic in dogs hasn’t been studied.

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Dosage Compounding Pharmacies Compounding Labelling 52

Pharmaceutical Technology

MARCH 23, 2023

The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. It is also being assessed in other tumour types and along with other Incyte pipeline compounds.

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FDA Adverse Reactions Compounding Chemotherapy 98

The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.

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FDA Controlled Substances Chemotherapy Compounding 69

European Pharmaceutical Review

OCTOBER 19, 2023

With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use. How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? What do you envision the future of radiopharmaceuticals to be like?

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Chemotherapy Compounding Immunization FDA 86