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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...
FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva...
Antibiotics Not Helpful for Cough Due to Lower Respiratory Tract Infection
Antibiotics have no measurable impact on the severity or duration of cough due to acute lower respiratory tract infection (LRTI) among adults presenting...
Hypertensive Disorders of Pregnancy Raise Risk for Postpartum Mortality for One Year
Hypertensive disorders of pregnancy (HDPs) are strong risk factors for pregnancy-associated mortality due to cardiovascular disease (CVD) at delivery through...
Clinical Study Identifies Personalized Treatment Options for Metastatic Non-Small Cell Lung Cancer With Plasma Proteome Testing
FORT MYERS, Fla., April 25, 2024. Florida Cancer Specialists & Research Institute, LLC (FCS) medical oncologist and hematologist Ernesto Bustinza-Linares,...
Occurrence of Low-Birth-Weight Babies Heightened in Active-Duty Servicewomen
Active-duty servicewomen in the United States appear to have an increased occurrence of low-birth-weight babies compared with nonservice women, according...
Differences ID'd in Tau Burden in Down Syndrome, Alzheimer Disease
The spatial distribution, timing, and magnitude of tau burden differs for people with Down syndrome and those with autosomal-dominant Alzheimer disease,...
U.S. Births Declined in 2023, Marking End to Post-Pandemic Rise
The short post-pandemic uptick in U.S. births may be over, with 2023 numbers showing a decline in births. According to provisional data from the U.S....
FDA Approves New Antibiotic Against UTIs, Pivya (pivmecillinam)
As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics. So, it's welcome news that the U.S. Food and...
New School Lunch Rules Target Added Sugars, Salt
School lunches will soon contain less added sugars and salt under new nutrition standards announced by the U.S. Department of Agriculture on Wednesday. “We...
Could Heartburn Meds Raise Your Migraine Risk?
People taking heartburn meds have a higher risk of migraines and other types of severe headaches, a new study warns. All classes of acid-reducing drugs...
Gene-Based Therapy Restores Cellular Development and Function in Brain Cells From People With Timothy Syndrome
In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and...
Neosporin Ointment in the Nose Might Be Potent Antibiotic
Want to prevent a respiratory infection? A fingerful of Neosporin antibiotic swabbed inside your nose might help you fight off a range of invading respiratory...
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots...
Stop Clopez Corp. Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil
April 22, 2024– Hollywood, FL, US, Stop Clopez Corp. is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has...
Abeona Therapeutics Provides Regulatory Update on Pz-cel
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration...
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Latest FDA New Drug Approvals
- Pivya Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.
- Ojemda Ojemda (tovorafenib) is a type II pan-RAF kinase inhibitor for the treatment of pediatric low-grade glioma.
- Anktiva Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 superagonist for use in combination with Bacillus...
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...
- Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.