FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence.

Labelling 59

Labelling Adverse Reactions Dosage 59

Express Pharma

JANUARY 15, 2025

The BLA submission is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modelling of observed data. Long-term data presented at the Alzheimers Association International Conference (AAIC) 2024 suggests that early and continuous treatment may prolong the benefits of therapy, even after plaque clearance.

Adverse Reactions 104

Adverse Reactions Labelling Hospitals 104

Express Pharma

DECEMBER 30, 2024

Efficacy and Safety The subcutaneous injection of nivolumab and hyaluronidase-nvhy was evaluated in CHECKMATE-67T (NCT04810078), a multicenter, randomised, open-label trial in patients with advanced or metastatic clear cell renal cell carcinoma who received no more than 2 prior systemic treatment regimens.

Adverse Reactions 52

Adverse Reactions Dosage Chemotherapy Labelling 52

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 7] A recent report from 2024 found that fluoride exposure is associated with lower IQ in children, which has brought the issue of fluoridation front and center again (the U.S.

Health and Personal Care Stores 64

Health and Personal Care Stores Labelling Immunization Immunity 64