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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...
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...
Avoid Raw Milk to Cut Risk of Bird Flu, Officials Urge
People drinking raw unpasteurized milk are at risk for potentially contracting bird flu, the U.S. Food and Drug Administration warned Wednesday. “We...
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...
Major Women's Health Study Supports Hormone Replacement Therapy in Early Menopause
Hormone replacement therapy can safely ease middle-aged women’s symptoms during early menopause, data from a major women’s health study show. Women...
Organic Walnuts Tied to Serious E. Coli Illnesses
Organic walnuts from a California grower that were distributed to health food and co-op stores in 19 states have been linked to serious cases of E. coli...
More Than Half of Cats on Farm Where Bird Flu Infected Cows Died After Drinking Milk
In yet another sign that bird flu is spreading widely among mammals, a new report finds more than half of cats at the first Texas dairy farm to have cows...
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...
Recently Added
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...
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...