Tag: fda
J&J COVID Vaccine Gets Unique CPT Code Even Before FDA Filing
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The largest US physician organization has created a billing code for...
FDA Approves First and Only Treatment for AL Amyloidosis
The first and only treatment for a rare and often fatal blood cell disorder has been approved in the United States. The new indication is...
FDA Welcomes Sotagliflozin Data for Heart Failure in Diabetes
The Food and Drug Administration has determined that data collected on the dual SGLT1/2 inhibitor sotagliflozin (Zynquista) for treating patients with type 2 diabetes in...
Biden Chooses Ex FDA Chief Kessler to Help Lead US Vaccine Drive
WILMINGTON, Del. (Reuters) – U.S. President-elect Joe Biden has chosen David Kessler, the ex-head of the Food and Drug Administration (FDA), to help lead the...
New Trump Administration Policies for FDA Under Fire
The Trump administration is making attempts in its final days to weaken regulation of medical products, say watchdog groups. The Department of Health and Human...
FDA Finalizes Guidance for Power Morcellators
Power morcellators can be safely used for some gynecologic surgeries, according to recent guidance from the US Food and Drug Administration (FDA), but doing so...
Agency Kept Independence With Science as Its ‘North Star’
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Some Trump administration appointees have resigned in protest of the riot...
FDA Warns of False Negative COVID Tests From Virus Mutations
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. US regulators warned about the potential risk for false negative results...
Curbing Itch Intensity, Frequency in Children With Severe Eczema
Dupilumab treatment with concomitant topical corticosteroids provided rapid and sustained improvement in itch intensity and frequency in children aged 6-11 years with severe atopic dermatitis....
Experts Debate Wisdom of Delaying Second COVID-19 Vaccine Dose
Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. A proposal to delay administration of the second dose of COVID-19 vaccines — suggested...
Explained: Where does the world stand in the race for a coronavirus vaccine?
India on Friday became the fourth country to approve a coronavirus vaccine developed by Oxford University and AstraZeneca, authorising the vaccine’s rollout in coming weeks...
Should vaccine volunteers now get the real thing?
Tens of thousands of Americans have volunteered to test COVID-19 vaccines, but only about half of them got the real thing during trials. Now, with...
COVID-19 Vaccine Rollout Faces Delays
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The COVID-19 vaccine distribution process in the U.S. is moving slower...
United States Buys 100 Million More Pfizer Vaccine Doses
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The Trump administration is buying 100 million additional doses of the...
Moderna’s Vaccine ‘Highly Effective,’ but Further Studies Needed
The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) evaluated Moderna’s COVID-19 vaccine as highly effective with a favorable safety profile, based...
FDA Clears Device to Remove Dead Pancreatic Tissue
The US Food and Drug Administration (FDA) has approved the EndoRotor System (Interscope, Inc) for removal of necrotic tissue in patients with walled-off pancreatic necrosis...
FDA Toughens REMS Requirements for Some Fentanyl Products
Concern about potentially inappropriate prescribing of transmucosal immediate-release fentanyl (TIRF) products has prompted the US Food and Drug Administration (FDA) to toughen requirements in the...
Type 1 Diabetes Screen Costing $55 Is Launched in US
A new initiative launched by the diabetes charity JDRF aims to broaden screening for type 1 diabetes risk for the general population of the United...
Novartis Receives FDA Complete Response Letter on Inclisiran
The US Food and Drug Administration (FDA) issued a complete response letter regarding Novartis’ new drug application (NDA) for inclisiran, a novel treatment for elevated...
FDA Approves Implant as Alternative to ACL Reconstruction
The US Food and Drug Administration (FDA) granted marketing authorization for an anterior cruciate ligament (ACL) implant, intended as an alternative to surgical reconstruction after...
FDA OKs First Oral Hormone Tx for Advanced Prostate Cancer
The US Food and Drug Administration (FDA) today approved an oral form of androgen deprivation therapy (ADT) known as relugolix (Orgovyx) for the treatment of...
Second COVID-19 Vaccine Ready for Use, CDC Panel Says
Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices...
FDA Grants Emergency Use for Moderna COVID-19 Vaccine
Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. As expected, the US Food and Drug Administration granted Moderna an emergency use authorization...
FDA Authorizes use of Moderna COVID-19 Vaccine
Dec. 18, 2020 — As expected, the FDA granted Moderna an emergency use authorization for its COVID-19 vaccine, doubling the number of vaccine doses expected...
Vaccine Rollout On Track, Expect 300M Doses Through March
Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU)...
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