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Neurocrine Biosciences Announces U.S. FDA Approval of Ingrezza Sprinkle (valbenazine) Capsules

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Ingrezza Sprinkle (valbenazine) capsules,...

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 Grants Full Approval for Tivdak to Treat Recurrent or Metastatic Cervical Cancer

(BUSINESS WIRE) April 29, 2024 -- Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) today announced the U.S. Food and Drug Administration (FDA) approves...

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...

Johnson & Johnson Will Pay $6.5 Billion to Settle Talc Ovarian Cancer Lawsuits

Johnson & Johnson announced Wednesday that it would pay out more than $6.5 billion over the next 25 years to settle existing lawsuits claiming that...

No Sign of Bird Flu in Ground Beef, USDA Says

After investigation, the U.S. Department of Agriculture said Wednesday that the nation's ground beef supply is so far testing negative for the presence...

U.S. Maternal Deaths Declined in 2022

The number of American women who died at or soon after childbirth declined significantly in 2022, the latest government data shows, but the rate is still...

Economy, Election Spur Rising Anxiety Among Americans in 2024

A looming presidential election, continued economic struggles and the threat of gun violence have a rising number of Americans more anxious this year compared...

Gilgamesh Announces Initiation of Phase 2a Trial of GM-1020 in Major Depressive Disorder

NEW YORK, May 1, 2024. Gilgamesh Pharmaceuticals, a clinical-stage neuroscience company committed to developing best-in-class, rapid-acting treatments...

Heart Health Varies With Race Among Sexual-Minority Females

For sexual-minority (SM) females, cardiovascular health (CVH) varies across race and ethnicity, according to a study published online May 1 in JAMA Network...

Pediatric Resource Use Less Likely With Legalization of Recreational Cannabis

In cases of cannabis intoxication in children, resource utilization is less likely in states with recreational legalization of cannabis, according to a...

Healthy Lifestyle Can Overcome Genetic Predisposition to Premature Death

Adherence to healthy lifestyles can largely overcome the genetic risk for a shorter lifespan, according to a study published online April 29 in BMJ Evidence...

Brief Provocation of Anger Adversely Affects Endothelial Health

A brief provocation of anger has an adverse effect on endothelial cell health, according to a study published online May 1 in the Journal of the American...

Scientists Discover How an Essential Nutrient Enters the Brain

Researchers have discovered that choline, an essential nutrient vital for brain health, is actively transported from the bloodstream into the brain by...

Monthly News Roundup - April 2024

FDA Approves First-in-Class Anktiva Plus BCG for Bladder Cancer In April the U.S. Food and Drug Administration (FDA) approved ImmunityBio’s Anktiva...

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,...

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...

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Recently added consumer and prescribing information: Rezenopy, Libervant, Beqvez, Xolremdi, Pivya, Xromi, Risvan, Voydeya, Winrevair, Pemgarda

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Latest FDA New Drug Approvals

  • Libervant Libervant (diazepam) is a buccal film formulation of the benzodiazepine diazepam that may be given to treat children aged 2 to 5 years with...
  • 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