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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...

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...

Following Drop After COVID-19 Onset, Inappropriate Antibiotic Prescribing Is Up

There was an initial decrease in inappropriate antibiotic prescriptions following onset of COVID-19, followed by an increase, according to a study published...

Osteoporosis Screening Rates Low for Asian American Medicare Beneficiaries

Rates of dual-energy X-ray absorptiometry (DXA) screening for osteoporosis are lower than expected for Asian American Medicare beneficiaries, according...

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...

Biden Administration Could Reclassify Marijuana as Less Risky Drug

The Justice Department has recommended that marijuana be reclassified as a less dangerous drug, a move that signals a significant shift in U.S. drug policy. The...

NRx Pharmaceuticals Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression

RADNOR, Pa., April 30, 2024, NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company today that its Breakthrough...

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,...

Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

(BUSINESS WIRE) April 29, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-10, a Phase...

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: Libervant, Beqvez, Xolremdi, Pivya, Xromi, Risvan, Voydeya, Winrevair, Pemgarda, Tryvio

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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...

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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