FDA releases the form FDA-483 with six observations from an inspection at the Cipla API and drug manufacturing facility in Ragaid, Maharashtra, India.
FDA grants breakthrough device designation to a Roche blood test intended to aid in a diagnosis of Alzheimers disease based on amyloid pathology.
FDA approves an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 1...
FDA clears a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder.
The American Society of Health-System Pharmacists says drug shortages are at the highest level since 2001.
During a 4/11 hearing , U.S. Representative Ro Khanna (D-CA) criticizes FDA and commissioner Robert Califf for not doing enough to prevent frivolous p...
A federal appeals court affirms a lower court decision barring FDA from approving a Norwich ANDA for a generic form of Salix Xifaxan until 10/2/2029.
FDA authorizes Seattle Childrens Therapeutics to launch a CAR T-cell trial to treat lupus in children.
