pharmaphorum

DECEMBER 23, 2020

The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. While Trodelvy is already conditionally approved in the US, the data showing the drug improved overall survival compared with chemotherapy could be enough for it to clinch a permanent licence in the US.

FDA 78

FDA Chemotherapy Compounding Vaccines 78

pharmaphorum

FEBRUARY 24, 2021

That compound (previously called TAK-580) was taken into a phase 1/2b trial in children with the brain cancer glioma before the Japanese drugmaker returned the rights after a review of its pipeline assets. It says the FDA has suggested that study could form the basis of a regulatory filing if response rate data are positive.

Chemotherapy 66

Chemotherapy Compounding FDA 66

The Checkup by Singlecare

MARCH 28, 2024

Veterinarians may use it in a cat to prevent nausea and vomiting due to chemotherapy. Pet parents will use tablets made for humans or mirtazapine custom-made by a compounding pharmacy. However, a veterinarian may supply mirtazapine in a liquid format made by a compounding pharmacy. Is mirtazapine safe for dogs?

Dosage 52

Dosage Compounding Pharmacies Compounding Labelling 52

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.

FDA 69

FDA Controlled Substances Chemotherapy Compounding 69

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.

FDA 98

FDA Adverse Reactions Compounding Chemotherapy 98

The Checkup by Singlecare

MARCH 23, 2023

Understanding the difference between CBD vs. marijuana Cannabinoids are compounds found in the cannabis plant, Cannabis sativa. The Food and Drug Administration (FDA) approved the drug to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. Marijuana , also called cannabis, contains more than 100 cannabinoids.

Controlled Substances 52

Controlled Substances Medical Records Chemotherapy Compounding 52

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?

Chemotherapy 92

Chemotherapy Compounding Immunization FDA 92

European Pharmaceutical Review

JANUARY 3, 2023

Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers, yet they can cause ototoxicity, permanent and irreversible hearing loss, which occurs in up to 50-60 percent of adult patients and 90 percent of paediatric patients who survive cancer. This control arm will provide natural history data.

Chemotherapy 52

Chemotherapy Compounding FDA 52

pharmaphorum

NOVEMBER 29, 2022

By enabling strong CD8 T-cell infiltration in cold tumor tissues, NT-I7, a compound developed by NeoImmuneTech, is capable of promoting a microenvironment that contributes to clinical efficacy, when combined with a CPI. Amplifying and reinvigorating persistent T cell immunity has become a much-needed path to enhance anti-tumor efficacy.

Immunization 104

Immunization Chemotherapy Compounding FDA 104

Pharmaceutical Technology

MARCH 29, 2023

AlgoTx remains on track to start enrolling subjects of a Phase II study of its compound ATX01 for the rare condition erythromelalgia in Q2 2023, says CEO Stéphane Thiroloix. In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia.

Chemotherapy 52

Chemotherapy Compounding Communication FDA 52

The FDA Law Blog

FEBRUARY 11, 2024

FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. In other words, no rescheduling. There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding FDA 59