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Latest From Michael Cipriano
'We have a lot of red tape, but we have a clear red tape,' attorney José Alberto Campos-Vargas says in an interview.
Mucodel has a oromucosal naloxone product in Phase I, and it wants US FDA to reconsider approval standards for intranasal products that are further along in development.
Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.
Measures are aimed at mitigating risk of suicidal ideation and behavior with the psoriasis drug, but company will not have to conduct a postmarketing registry to evaluate this risk.
Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.
US FDA obliges hypothesis-testing observational study to determine whether there is an association with gastrointestinal bleeding and the drug; postmarketing requirements usually seek to determine frequency between a drug and adverse events known to be associated.