Tag: u.s. food and drug administration

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...

Controversy Flares Over Ivermectin for COVID-19

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The National Institutes of Health (NIH) has dropped its recommendation against...

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...

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...

Moderna’s COVID-19 Vaccine Efficacy Confirmed in NEJM Study

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The recently authorized COVID-19 vaccine developed by Moderna and the National...

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...

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)...