FDA approves first artificial iris
FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris
Archive for the ‘Drug Safety Information Podcasts’ category
Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo
FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak
Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act
FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients
FDA approves new treatment for moderately to severely active ulcerative colitis
FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
FDA approves a new treatment for PKU, a rare and serious genetic disease
The FDA today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit
OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious […]
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens
The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure
FDA approves Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure.
FDA approves novel preventive treatment for migraine
FDA approves Aimovig for the preventive treatment of migraine. Aimovig works by blocking the activity of a molecule that is involved in migraine attacks.
FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products
FDA continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette makers requiring them to submit important documents to better understand the youth appeal.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
FDA statement on certain tactics drug makers may be pursuing to delay generic competition
FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
FDA approves first epoetin alfa biosimilar for the treatment of anemia
FDA approves Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan