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Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication
Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an expanded indication for Clinolipid...
FDA Approves Updated Altuviiio Label With Expanded Pediatric Data Confirming Highly Effective Bleed Protection in Children With Hemophilia
The US Food and Drug Administration (FDA) has updated the label for Altuviiio® [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]...
SUPERNOVA Phase III trial of Sipavibart Long-Acting Antibody Met Primary Endpoints in Preventing COVID-19 in Immunocompromised Patient Population
Positive high-level results from the SUPERNOVA Phase III COVID-19 pre-exposure prophylaxis (prevention) trial showed AstraZeneca’s sipavibart (formerly...
Elinzanetant Significantly Reduces Frequency and Severity of Moderate to Severe Hot Flashes Associated with Menopause
Berlin, May 16, 2024 – Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2, showing that the investigational compound...
Web-Based Self-Help Intervention Beneficial for Binge Eating Disorder
For patients with binge eating disorder (BED), a web-based cognitive behavioral self-help intervention leads to significant reductions in binge eating...
2015 to 2021 Saw Increase in Electronic Vaping Product Use in Teens
From 2015 to 2021, there were significant increases in the use of electronic vapor products (EVPs) among adolescents, according to a study published in...
Semaglutide Reduces Need for Diuretics in Heart Failure
Semaglutide reduces the need for loop diuretics and has positive effects on symptoms, physical limitations, and body weight in patients with heart failure...
Slight Decline Seen in U.S. Drug Overdose Deaths
New 2023 provisional data from the National Center for Health Statistics show the first decline in deaths from drug overdose in the United States since...
Spread of Deadlier Mpox Strain in Africa Has CDC Concerned
The central African nation of the Democratic Republic of Congo (DRC) is battling a record number of cases of mpox, fueled by a strain with a higher death...
Plant-Based Diets Lower Risk of Heart Trouble, Cancer and Death
Following a vegetarian or vegan diet might just buy you a longer, healthier life, a new review finds. Staying away from meat was tied to a reduced risk...
Brain Decline, Dementia Common Among Older American Indians
Higher rates of blood vessel-damaging conditions like hypertension or diabetes may be driving up rates of cognitive decline and dementia among older American...
Cream Cheese From Aldi, Hy-Vee Stores Recalled Due to Salmonella Risk
Two major supermarket chains, Aldi and Hy-Vee, are recalling brands of cream cheese because of a potential risk for salmonella. No actual illnesses linked...
Plant-Based Diets Tied to Long-Term Health Benefits
Plant-based diets appear beneficial in lowering cardiometabolic risk factors, as well as cardiovascular diseases (CVDs), cancer risk, and mortality, according...
Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in...
FDA Safety Communication: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results
The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests...
Cyberattack Cripples Major U.S. Health Care Network
Ascension, a major U.S. health care system with 140 hospitals in 19 states, announced late Thursday that a cyberattack has caused disruptions at some of...
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Recently added consumer and prescribing information: Myhibbin, Rezenopy, Libervant, Beqvez, Xolremdi, Pivya, Xromi, Risvan, Voydeya, Winrevair
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Latest FDA New Drug Approvals
- Imdelltra Imdelltra (tarlatamab-dlle) is a first-in-class, bispecific delta-like ligand 3 (DLL3)-directed CD3 T cell engager indicated for the...
- Myhibbin Myhibbin (mycophenolate mofetil) is an antimetabolite immunosuppressant used for the prophylaxis of organ rejection.
- 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...
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...