Tag: united states food and drug administration

FDA to Add Myocarditis Warning to mRNA COVID-19 Vaccines

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) is adding a warning...

Hormone Pellet Safety Data ‘Not Very Reassuring at All’ for Women

Women who receive pellet hormonal therapy may be significantly more likely to have side effects such as mood swings, anxiety, breast tenderness, hair pattern change,...

Watchdog Group Wants FDA Leaders Removed for Okaying Aducanumab

A high-profile, Washington-based consumer advocacy group is calling for the removal of the US Food and Drug Administration’s (FDA’s) acting commissioner and two other top...

FDA Approves 20-Valent Pneumococcal Vaccine (Prevnar)

The FDA has approved a novel pneumococcal 20-valent conjugate vaccine capable of protecting against 20 serotypes implicated in most cases of invasive pneumococcal disease (IPD)...

Biden Kept His Promise to Increase COVID Testing Capacity

Before vaccinations were widely available, covid-19 tests were considered one of the few tools to help control the spread of the coronavirus. That’s why then-candidate...

Moderna Seeks FDA OK for Adolescent COVID Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Moderna has filed for emergency use authorization from the U.S. Food...

Benzene Was Found in Some Sunscreens. Now What?

Just before Memorial Day, online pharmacy and lab Valisure announced that its testing had found benzene, a known carcinogen, in batches of 78 widely-available sunscreen...

FDA Approves ‘Gamechanger’ Semaglutide for Weight Loss

The US Food and Drug Administration (FDA) has approved a 2.4 mg/week subcutaneous dose of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy, Novo Nordisk)...

Novel Drug Approved by FDA for Some Bile Duct Cancers

A novel drug, infigratinib (Truseltiq), is now available in the United States for adults with previously treated unresectable bile duct cancer harboring a fibroblast growth...

FDA Okays New Drug Option for Schizophrenia, Bipolar I Disorder

The US Food and Drug Administration (FDA) has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the...

FDA Approves Ozanimod (Zeposia) for Ulcerative Colitis

The US Food and Drug Administration (FDA) has approved ozanimod (Zeposia) for adults with moderately to severely active ulcerative colitis (UC), the company has announced....

First Drug for Lung Cancer With KRAS Mutation Gains FDA Approval

The first drug to target KRAS mutations in non-small cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration. KRAS mutations...

Many Sunscreens Have a Carcinogen, Pharmacy Tells FDA

Summer is around the corner, and with the pandemic waning for many, the CDC encourages people to spend more time unmasked outdoors. But protecting yourself...

FDA Restricts Obeticholic Acid Over Serious Liver Injury Risk

The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the US Food and Drug Administration (FDA) to restrict its use...

Corporations Encourage Employee Vaccination

Many of the companies with the largest number of employees say they’ll do almost anything to encourage their employees to get vaccinated. But a survey...

FDA OKs First Targeted Therapy for Subset of Patients With NSCLC

The US Food and Drug Administration (FDA) today granted an accelerated approval for amivantamab (Rybrevant) as the first targeted treatment for patients with non–small cell...

Paclitaxel Devices Exonerated in Real-World Data

A cohort analysis using advanced strategies to minimize the impact of confounders has concluded that the current Food and Drug Administration warning about paclitaxel-coated devices...

FDA Blazes Path for ‘Real-World’ Evidence as Proof of Efficacy

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jumpstart awareness of the potential role of this new...

Majority of Parents Will Wait on Kids’ COVID Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Three-quarters of parents don’t plan to vaccinate their kids against COVID-19...

Some NP Thyroid Lots Recalled Due to Reduced Potency

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid...

FDA Panel Votes Against Two Cancer Indications but Backs 4 of 6

Federal advisers this week supported the efforts of pharmaceutical companies in 4 of 6 cases in which these firms are fighting to maintain cancer indications...

Once-Nightly Sodium Oxybate Agent Effective in Narcolepsy

A novel, once-nightly formulation of sodium oxybate is safe and effective for treating both subjective and objective symptoms of narcolepsy, new research suggests. Top-line results...

FDA Approves Dapagliflozin (Farxiga) for Chronic Kidney Disease

The US Food and Drug Administration (FDA) has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and...

Hand Sanitizers May Contain Toxic Methanol

Nearly a dozen scented hand sanitizer sprays sold at Ulta, TJ Maxx, and Marshalls stores nationwide are being recalled because they may be contaminated with...

Potential First-in-Class Schizophrenia Drug Cuts Negative Symptoms

The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows. Results of...