FDA
FDA issues warning letter to Zhejiang Huahai Pharmaceutical involved in valsartan recall  NEWS MEDICAL · 2 days
The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China,... more
UMGCCC uses Gammapod radiotherapy to treat breast cancer patients  NEWS MEDICAL · 1 week
Radiation oncologists at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center are now treating patients with the GammaPod™, a new FDA-cleared radiation therapy for early-stage breast cancer. more
Physician-scientists present updated efficacy data on CAR T-cell gene immunotherapy  NEWS MEDICAL · 1 week
Physician-scientists from Children's Hospital of Philadelphia presented updated efficacy and safety data on Kymriah--the first-ever U.S. Food and Drug Administration approved personalized CAR T-cell gene immunotherapy for aggressive... more
FDA takes significant step forward in driving development of novel genetic tests  NEWS MEDICAL · 1 week
The U.S. Food and Drug Administration today took a significant step forward in driving the efficient development of novel diagnostic technologies that scan a... more
FDA approves new combination therapy for acute myeloid leukemia  NEWS MEDICAL · 2 weeks
Older patients with acute myeloid leukemia (AML) often aren't healthy enough to receive intensive chemotherapy, and gentler treatments aren't very effective in treating this aggressive blood cancer. more
FDA approves new drug for treatment of rare autoimmune disorder  NEWS MEDICAL · 2 weeks
The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. more
First biosimilar approved by FDA for treatment of adult patients with non-Hodgkin’s lymphoma  NEWS MEDICAL · 2 weeks
The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult... more
At FDA, a new goal, then a push for speedy device reviews  ABC NEWS · 2 weeks
Under pressure from industry, FDA sought to be "first in the world" to approve new medical devices. Some former officials say the focus on... more
Insulin pumps have most reported problems in FDA database  ABC NEWS · 2 weeks
Insulin pumps are used by hundreds of thousands of diabetics around the word. Companies say they help them live normal lives. But AP investigation found that when it comes to... more
Breakthrough cancer drug may have saved this 9-year-old's life  ABC NEWS · 2 weeks
A newly FDA-approved breakthrough cancer drug could help thousands of people every year and it's already giving hope to a family who thought they were out of options. more
US goal to be "first" on devices worries former regulators  ABC NEWS · 2 weeks
Under pressure from industry, FDA sought to be "first in the world" to approve new medical devices. Some former officials say the focus on cheaper, faster reviews poses... more
FDA's 'flawed' device pathway persists with industry backing  ABC NEWS · 2 weeks
The nation's top medical experts have called the FDA's main system for clearing medical devices "flawed." Yet the 42-year-old system persists, backed by millions in industry lobbying dollars more
FDA says some romaine lettuce is safe to eat after E. coli outbreak  ABC NEWS · 2 weeks
To help shoppers identify potentially contaminated lettuce, producers are going to start labeling the source of their greens along with a harvest... more
FDA says some romaine lettuce is safe to eat  ABC NEWS · 2 weeks
To help shoppers identify potentially contaminated lettuce, producers are going to start labeling the source of their greens along with a harvest date. more
WATCH: Romaine lettuce from California linked to E. coli, FDA says  ABC NEWS · 2 weeks
The FDA is advising consumers to buy lettuce that's harvested from areas outside of northern and central California. more
Stratasys and Materialise bring 3D printed medical models to life  NEWS MEDICAL · 2 weeks
Further bringing 3D printed medical models to life, Stratasys is expanding the suite of printers and materials validated by its collaborator Materialise as part of FDA-cleared Materialise Mimics... more
Using molecular targeting approach to kill melanoma cells  NEWS MEDICAL · 2 weeks
In 1960, scientists described the "Philadelphia chromosome" that causes chronic myeloid leukemia, and in 2001 the Food and Drug Administration approved the drug imatinib to disable the action of this cancer-causing genetic... more
FDA grants accelerated approval to oncology drug for treatment of key genetic driver of cancer  NEWS MEDICAL · 2 weeks
The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and... more
FDA says it will overhaul criticized medical device system  ABC NEWS · 3 weeks
US officials say they plan to overhaul a decades-old system for approving most medical devices, after global investigation more
Improving medical device tracking a slow, imperfect process  ABC NEWS · 3 weeks
The FDA is slowly rolling out a plan to put unique identification codes on medical devices to better track problems, but hurdles to improving patient safety persist more
FDA to overhaul long-criticized medical device system  ABC NEWS · 3 weeks
US officials plan to overhaul decades-old system for approving most medical devices, after global investigation more
US FDA plans overhaul of decades-old medical device system  ABC NEWS · 3 weeks
US officials plan to overhaul decades-old system for approving most medical devices, after global investigation more
Device treating pain draws thousands of injury reports  ABC NEWS · 3 weeks
Spinal-cord stimulators treat people suffering from chronic pain. Device makers say they're safe. But AP investigation shows they're more dangerous than patients know, accounting for the third-highest number of medical-device injuries reported... more
FDA approves new treatment for AML patients  NEWS MEDICAL · 3 weeks
The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in... more
4 Infant Botulism Cases Linked to Honey-Dipped Pacifiers  LIVE SCIENCE · 3 weeks
The FDA warns caregivers not to give honey to infants younger than 12-months more
Podcast: KHN’s ‘What the Health?’ Health nerd books for the holidays  NEWS MEDICAL · 3 weeks
The Food and Drug Administration took some serious steps toward curbing teen use of tobacco and nicotine products this month, including proposing a virtual ban on... more
New drug shows promise for treating people with peanut allergy  NEWS MEDICAL · 4 weeks
Controlled ingestion of peanut protein could help build tolerance in peanut allergy sufferers. Authors of a new study published in the New England Journal of Medicine say an... more
Medical News Today: 'Breakthrough' treatment for peanut allergy awaits FDA check  MNT · 4 weeks
Millions of people live with peanut allergy, for which there is currently no available treatment. Thanks to a new study, though, this may soon change. more
New treatment to protect people with peanut allergies ready for FDA review  SCIENCE DAILY · 4 weeks
Medical researchers have developed a new treatment for protection against accidental exposure to peanut. more
FDA approves antibacterial drug to treat travelers' diarrhea  NEWS MEDICAL · 4 weeks
The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli),... more
New first-line treatment for peripheral T-cell lymphoma approved by FDA  NEWS MEDICAL · 4 weeks
The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral... more
FDA restricts the sale of some flavored e-cigarettes as teen use soars  SCIENCE-NEWS · 4 weeks
The Food and Drug Administration announced restrictions on the sale of some e-cigarette flavors in response to a drastic rise in teen’s use of... more
Drug used to treat dizziness may slow down growth of triple-negative breast cancer  NEWS MEDICAL · 4 weeks
Screening Food and Drug Administration approved compounds for their ability to stop cancer growth in the lab led to the finding that... more
Non-surgical fistula creation system Ellipsys becomes key focus of attention at CiDA  NEWS MEDICAL · 4 weeks
The FDA-approved Ellipsys Vascular Access System from Avenu Medical, Inc., became a key focus of attention throughout last week's Controversies in Dialysis Access 15th... more
FDA announces new actions to limit sale of e-cigarettes to youth  NEWS MEDICAL · 4 weeks
The University of Texas MD Anderson Cancer Center applauds new actions announced today by the U.S. Food and Drug Administration to limit the sale of most... more
FDA to crack down on menthol cigarettes, flavored vapes  ABC NEWS · 4 weeks
FDA pushes for ban on menthol in cigarettes and tightened rules to prevent sale of flavored e-cigarettes to kids more
FDA warns against use of unapproved pain medications with implanted pumps  NEWS MEDICAL · 4 weeks
The U.S. Food and Drug Administration today alerted health care providers and patients about the serious complications that can occur when using medications not approved for... more
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