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FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring...

FDA Approves Xolremdi (mavorixafor) for Use in Patients with WHIM Syndrome

X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S....

FDA Approves Hercessi (trastuzumab-strf), a Biosimilar to Herceptin

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care...

FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B

(BUSINESS WIRE) April 26, 2024 -- Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene...

FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections

Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract...

FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated...

USPSTF Recommends Breast Cancer Screening for Women Aged 40 to 75 Years

The U.S. Preventive Services Task Force (USPSTF) recommends breast cancer screening for women aged 40 to 75 years, but evidence is insufficient for older...

Stigma Affects Quality of Life in Children With Chronic Skin Conditions

Health care professionals should consider stigmatization and bullying in assessing the social and mental health of children and adolescents with chronic...

Recommended Treatment for STIs More Likely in Public Versus Private Health Care Settings

Individuals seen for sexually transmitted infections (STIs) by clinicians in a private U.S. health care setting are less likely to receive recommended...

Survival Gains Seen With Assignment to Experimental Group in Cancer Trials

For patients with solid tumors, assignment to an experimental group in trials of investigational drugs yields significant survival gains, according to...

All Women Need Mammograms Beginning at Age 40, Expert Panel Says

All women should start getting mammograms every other year beginning at age 40, the nation’s top panel of preventive health experts announced Tuesday.About...

When in Life Are Folks Most Lonely?

At what age does loneliness strike adults the hardest?A new review maps it out, finding that people are more lonely as young adults, grow less lonely as...

Staying Fit Boosts Kids' Mental Health

The benefits of physical fitness for kids spill over into their mental health, new research shows.Getting plenty of exercise may guard against depressive...

USDA Testing Beef Amid Bird Flu Outbreak in Dairy Cows

As bird flu continues to spread among dairy cows, the U.S. Department of Agriculture said Monday it is now testing ground beef for any presence of the...

FDA Alerts Health Care Professionals of Pregnancy Problems Associated with Thiopurines

FDA is alerting health care professionals of the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines (azathioprine,...

Lower Dose of Mpox Vaccine is Safe and Generates Six-Week Antibody Response Equivalent to Standard Regimen

A dose-sparing intradermal mpox vaccination regimen was safe and generated an antibody response equivalent to that induced by the standard regimen at six...

Which Patients and Surgeries Are 'High Risk' for Seniors?

Most seniors probably view any emergency surgery with a certain level of anxiety. Now, a new study seeks to sort out who might be at highest risk for...

Analysis Identifies 50 New Genomic Regions Associated with Kidney Cancer Risk

In a new analysis of genetic susceptibility to kidney cancer, an international team of researchers has identified 50 new areas across the genome that are...

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Recently added consumer and prescribing information: Xolremdi, Pivya, Xromi, Risvan, Voydeya, Winrevair, Pemgarda, Tryvio, Edurant and Edurant Ped, Tevimbra

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Latest FDA New Drug Approvals

  • Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.
  • Xolremdi Xolremdi (mavorixafor) is a CXC chemokine receptor 4 (CXCR4) antagonist indicated in patients 12 years of age and older with WHIM syndrome...
  • Hercessi Hercessi (trastuzumab-strf) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing...

More FDA approvals

Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...

More drugs in development