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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...

Key Therapy Equally Effective for Women, Men With Narrowed Leg Arteries

Peripheral artery disease (PAD) involves a debilitating narrowing of arteries in the legs, and the National Institutes of Health estimates that 1 in every...

Overall Cancer Risk Not Increased for Children Born After Assisted Reproduction

The overall risk for cancer is not increased for children born after medically assisted reproduction (MAR), according to a study published online May 2...

2020 Cancer Screening Rates Low at Federally Qualified Health Centers

In 2020, there were major gaps in screening clients at federally qualified health centers (FQHCs) for various types of cancer when compared with the general...

Risk for Most Cardiovascular Diseases No Higher With Inflammatory Bowel Disease

Among postmenopausal women with inflammatory bowel disease (IBD), there is no higher risk for cardiovascular disease (CVD) compared with women without...

Relationship With Therapist Predicts Outcomes of Psychedelic Therapy

A strong relationship between the therapist and participant is associated with long-term outcomes of psychedelic-assisted therapy, according to a study...

Doctors Describe Texas Dairy Farm Worker's Case of Bird Flu

Doctors in Texas are describing the only known human case of H5N1 avian flu connected to the ongoing outbreak of the disease in dairy cows.Bird flu in...

Does Preschool Boost Kids' Long-Term Academic Success? Study Finds Mixed Results

Pre-kindergarten programs have long been considered an early ticket to future success for children.But the evidence is much more mixed than one might think...

AI Might Spot Rare Diseases in Patients Years Earlier

Artificial intelligence might be able to identify patients who have rare diseases years earlier than they would typically be diagnosed, a new study says.A...

Amolyt Pharma Granted FDA Fast Track Designation for Eneboparatide for the Treatment of Hypoparathyroidism

Lyon, France, and Cambridge, MA, May 2, 2024 — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine...

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...

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...

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,...

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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...

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