bioequivalence

Warning letter
Pharma

Alembic site hit with warning letter on patient consent concerns

After a March inspection yielded a Form 483, Indian generics juggernaut Alembic has received a harsher reprimand from the FDA.
Fraiser Kansteiner Jul 21, 2026 11:40am
A graphic displaying a cross-section of the kidneys

Unicycive's pivotal trial of Takeda kidney drug rival hits goal

Jan 3, 2023 7:30am
FDA Building 2

FDA shares advice on bioequivalence of different dosage forms

Aug 24, 2021 7:45am
humiragood

Humira threat rises as Fujifilm biosim clears PhIII

Oct 20, 2016 8:36am