FDA Panel Recommends Centocor’s Ustekinumab Approval; Questions Dosing
Centocor should conduct additional studies of ustekinumab to evaluate potential interim doses, according to FDA's Dermatologic and Ophthalmic Drugs Advisory Committee
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ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.