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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 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...
Doctors Seeing More Atypical, Severe Symptoms in Patients With Syphilis
Physicians are increasingly seeing cases of syphilis that do not present with typical symptoms, such as rash or skin ulcers, according to a new report...
More Medical Lab Tests Will Soon Face Federal Scrutiny, FDA Says
Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by U.S. Food and Drug Administration,...
Intensive HTN Treatment Cuts Early T2D Diagnosis-Linked CVD Event Risk
More intensive hypertensive therapy significantly reduces the excess risk for cardiovascular disease (CVD) events associated with earlier hypertension...
Multisite QI Collaborative Increases Appropriate Pediatric Antibiotic Use
A multisite collaborative increases appropriate antibiotic use for pediatric community-acquired pneumonia, skin and soft tissue infections, and urinary...
Cabozantinib Promising for Metastatic Pheochromocytomas, Paragangliomas
For patients with metastatic pheochromocytomas and paragangliomas (MPPGs), an antiangiogenic multi-tyrosine kinase inhibitor, cabozantinib, is promising,...
FDA Says First Round of Tests Show No Live Virus in Pasteurized Milk
Live bird flu virus has not been found in any of the first batch of retail milk samples tested, federal health officials said Friday. Amid an ongoing...
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,...
King Charles Returns to Duties After Cancer Treatment
Britain's King Charles III is back to resuming his royal duties following treatment for cancer, Buckingham Palace announced Friday. "His Majesty The King...
Biden Administration Delays Menthol Cigarette Ban
A long-awaited ban on menthol cigarettes has been delayed indefinitely, the Biden administration said Friday. “This rule has garnered historic attention,...
Lower Dose of Mpox Vaccine is Safe and Generates Six-Week Antibody Response Equivalent to Standard Regimen
A dose-sparing intradermal mpox vaccination regimen was safe and generated an antibody response equivalent to that induced by the standard regimen at six...
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...
Analysis Identifies 50 New Genomic Regions Associated with Kidney Cancer Risk
In a new analysis of genetic susceptibility to kidney cancer, an international team of researchers has identified 50 new areas across the genome that are...
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Recently added consumer and prescribing information: Xolremdi, Pivya, Xromi, Risvan, Voydeya, Winrevair, Pemgarda, Tryvio, Edurant and Edurant Ped, Tevimbra
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Latest FDA New Drug Approvals
- Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.
- 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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