Tag: Food & Drug Administration
FDA Approves Inflectra as ‘Biosimilar’ to Remicade
For adults with Crohn's, rheumatoid arthritis, or psoriasis
FDA Approves First Tx for Disease Linked to Stem Cell Transplant
Hepatic veno-occlusive disease is rare, but fatal
FDA Wants Generic Opioids to Be Abuse-Deterrent
One more step to combat the epidemic of opioid abuse
FDA Approves Cinqair for Severe Asthma
Lab-developed interleukin-5 antagonist monoclonal antibody helps reduce blood levels of eosinophils
FDA Orders Enhanced Warning Labels on Opioid Pain Medications
New labeling rules mostly aimed at immediate-release versions of opioids
FDA Approves Anthim for Treating Inhalation Anthrax
Anthim, combined with certain antibacterial drugs, designed to neutralize anthrax toxins
FDA Gives Tentative Approval to Tests of Gene-Modified Mosquitos
Agency says testing the insects in Florida Keys poses little risk to people, animals, the environment
FDA Approves Xalkori for Rare Genetic Form of Lung Cancer
Drug approval expanded to include patients with ROS1-positive NSCLC
FDA: Guidance to Help Prevent Donor-Related Zika Infection
Part of FDA's ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission
FDA Adds Boxed Warning Requirement to Essure Device
In addition, manufacturer Bayer must conduct further study of real-world risks
