A lengthy FDA Warning Letter details issues at Indias Global Pharma Healthcare that led to contaminated ophthalmic drugs.
Bayer withdraws its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic th...
Federal Register notice: FDA renews the Nonprescription Drugs Advisory Committee for an additional two years.
Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studied effect of FDA-reg...
FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer drugs years after the...
Cardinal Health recalls its latest version (6/2023) of its Monoject syringes branded as Cardinal Health Monoject syringes because their dimensions dif...
Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvements.
AstraZeneca says its Imfinzi failed to achieve statistical significance in the PACIFIC-2 trial in some non-small cell lung cancer patients.
