CytoDyn files a BLA for Pro 140 (leronlimab (PRO 140) for use in combination therapy for treating HIV infection.
A CDER online post stresses the need for accurate in vitro to in vivo translation of data as part of new drug development to treat the novel coronavir...
An FDA-issued safety alert warns health care professionals about the temporary absence of a paralyzing agent warning statement on the vial caps of two...
FDA warns LifeHealth Science that its OR product is considered to be an unapproved and misbranded new drug and also violates dietary supplement requir...
Federal Register notice: FDA announces its process for publishing FDA Emergency Use Authorizations for medical devices related to the Covid-19 public ...
FDA publishes interim levels of certain ethanol impurities that would be acceptable in hand sanitizers during the Covid-19 public health emergency.
Amneal recalls all lots of metformin HCl extended-release tablets after FDA analysis finds unacceptable levels of NDMA.
Public Citizen says many organizations opposing plans to make Covid-19 treatments and vaccines affordable have received drug industry funding over the...