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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...
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...
CDC: Decrease in Maternal Mortality Rates Seen in 2022
In 2022, there was a decrease in maternal mortality rates, according to a report published in the May Health E-Stats, a publication of the U.S. Centers...
Neoadjuvant Chemohormonal Therapy Aids Locally Advanced Prostate Cancer
For patients with locally advanced prostate cancer, neoadjuvant chemohormonal therapy (NCHT) is beneficial for biochemical progression-free survival (bPFS),...
Algorithm From EHR Can ID Common Variable Immunodeficiency Disease
A machine learning algorithm can identify patients with common variable immunodeficiency disease (CVID) from their electronic health records, according...
Video-Only Noninferior to In-Person Therapy After Thumb Carpometacarpal Arthroplasty
For upper-extremity function after thumb carpometacarpal (CMC) arthroplasty, video-only therapy (VOT) is noninferior to in-person therapy (IPT), according...
EPA Earmarks $3 Billion to Replace Lead Pipes Nationwide
THURSDAY, May 2, 2024 — The U.S. Environmental Protection Agency (EPA) said it will spend $3 billion to help states and territories identify and...
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...
A Third of Young Adults Still Believe 'Tan Is Healthier' Myth: Survey
Brianna Starr, 29, didn’t think twice about sunbathing without sunscreen, hoping to get a golden tan that to many connotes health and beauty.But when...
MRNA Vaccine Fights Deadly Brain Tumor in Small Trial
An experimental cancer vaccine can quickly reprogram a person’s immune system to attack glioblastoma, the most aggressive and lethal form of brain cancer,...
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...
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...
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