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FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care...
FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
(BUSINESS WIRE) October 11, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq)...
FDA Approves Itovebi (inavolisib) for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
October 10, 2024 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib),...
FDA Approves Hympavzi for Hemophilia
The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding...
Risk for Suicidal Ideation, Attempts Down With GLP1-RA Treatment in Teens With Obesity
For adolescents with obesity, glucagon-like peptide 1 receptor agonist (GLP1-RA) treatment is associated with a reduced risk for suicidal ideation or attempts,...
3 Years of Med School Might Be Enough to Produce Quality Doctors
It’s typically thought that medical school requires four years of study after graduating college. But doctors might be able to shave a year off...
American Thoracic Society Provides Tips for Hospitals to Manage IV Fluid Supply Amid Shortage
The American Thoracic Society is providing tips to help hospitals mitigate impacts on intravenous (IV) fluid supply resulting from manufacturing disruptions...
Lithium Aspartate Not Effective for Neurologic Long COVID Fatigue
Lithium aspartate is not effective for neurologic post-COVID-19 condition (PCC) symptoms of fatigue and cognitive dysfunction, according to a study published...
FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now
Pharmacists may continue making compounded versions of the weight-loss medication tirzepatide while the U.S. Food and Drug Administration revisits its...
Half of Patients With Sepsis Die Within 2 Years, Hospital Study Finds
Half of people who develop blood poisoning, otherwise known as sepsis, are dead within a couple of years, a new study finds. A little more than 50% of...
Could Dad's Sperm Raise Odds for Common Complications of Pregnancy?
Some men might have damaged sperm that will increase the risk of pregnancy complications and health problems in newborns, a new study finds. DNA defects...
GSK Announces Positive Phase III Results from ANCHOR Trials for Depemokimab in Chronic Rhinosinusitis with Nasal Polyps
GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III clinical trials ANCHOR-1 and ANCHOR-2, which assessed the efficacy...
Data presented from the Phase 1b Clinical Trial Evaluating Low-Dose LTI-03 in Idiopathic Pulmonary Fibrosis
AUSTIN, Texas, Oct. 12, 2024 . Aileron Therapeutics, Inc. ("Aileron"), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines...
Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome
NEEDHAM, Mass., Oct. 11, 2024 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage...
Here's Where Viruses Love to Lurk in Your Bathroom
The bad news first: shower heads and toothbrushes in an average bathroom are teeming with an extremely diverse collection of viruses, most of which have...
U.S. Food and Drug Administration (FDA) Accepts New Drug Application for Elinzanetant
Berlin, October 9, 2024 – Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application...
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Recently added consumer and prescribing information: Imuldosa, Hympavzi, Flyrcado, Otulfi, Tecentriq Hybreza, Pavblu, Livdelzi, Yorvipath, Crexont, Lymphir
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Latest FDA New Drug Approvals
- Imuldosa Imuldosa (ustekinumab-srlf) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis...
- Hympavzi Hympavzi (marstacimab-hncq) is a tissue factor pathway inhibitor (TFPI) antagonist used for the treatment of adults and adolescents with...
- Itovebi Itovebi (inavolisib) is a phosphatidylinositol 3-kinase (PI3K) alpha inhibitor used for the combination treatment of PIK3CA-mutated...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...
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