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FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog
Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for the improvement of glycemic...
FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva
INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the...
FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to Prolia
INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the...
FDA Approves Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for Prevention of Invasive Meningococcal Disease Caused by Serogroups A, B, C, W, and Y
London, UK - 15 February 2025 - GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal...
FDA Approves Vimkunya (chikungunya vaccine, recombinant) for Prevention of Disease Caused by Chikungunya Virus
COPENHAGEN, Denmark, February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor
Osaka, Japan and Waltham, Massachusetts, February 14, 2025 – Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino;...
New York Sues Vape Companies for Marketing to Youth, Violating Flavor Ban
New York Attorney General Letitia James filed a major lawsuit yesterday, accusing 13 e-cigarette companies of illegally selling flavored vapes and targeting...
Vaccine Shows Promise for Pancreatic Cancer, Study Finds
Adding a personalized mRNA vaccine to standard treatment could offer new hope for pancreatic cancer patients, a small yet promising study from Memorial...
Water, Plain Milk Are the Healthiest Drinks for Kids
Got milk? It turns out, plain cow’s milk, water and a bit of veggie juice are still the best drink choices for kids and teens.That's the consensus of...
Dangerous Blood Clot Sidelines NBA Star Victor Wembanyama for the Season
One of the NBA's most exciting rising stars will spend the rest of the 2024-2025 season on the bench. Victor Wembanyama, the San Antonio Spurs' 7-foot...
Higher Calcium Intake Linked to Reduced Colorectal Cancer Risk
Higher calcium intake is associated with reduced colorectal cancer (CRC) risk across tumor sites and calcium sources, according to a study published online...
Epidural Steroid Injections Reviewed for Radicular Pain, Spinal Stenosis
There is some evidence for epidural steroid injections (ESIs) reducing pain and disability in cervical and lumbar radiculopathies and possibly in lumbar...
Acalabrutinib-Venetoclax Prolongs Survival in Previously Untreated Leukemia
For patients with previously untreated chronic lymphocytic leukemia (CLL), fixed-duration acalabrutinib-venetoclax with or without obinutuzumab significantly...
Olpasiran Leads to Significant Reduction in Oxidized Phospholipids
Olpasiran, a small interfering RNA, which blocks lipoprotein(a) (Lp[a]) production, leads to a significant and sustained reduction in oxidized phospholipids...
Clarity Receives US FDA Fast Track Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer Patients with Cu-67 SAR-bisPSMA
Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical...
PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application...
Boehringer’s Zongertinib Receives Priority Review from U.S. FDA for the Treatment of HER2 (ERBB2)-Mutant Advanced Non-Small Cell Lung Cancer
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib...
Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma
Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients...
Flu and Stomach Bugs Are Spreading Fast—Are You Prepared?
Flu season is in full swing, making it more important than ever to take steps to protect yourself and your loved ones. Dr. Priya Soni, a pediatric infectious...
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Recently added consumer and prescribing information: Opdivo Qvantig, Alyftrek, Crenessity, Ensacove, Steqeyma, Yesintek, Revuforj, Danziten, Aucatzyl, Emrosi
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Latest FDA New Drug Approvals
- Merilog Merilog (insulin aspart-szjj) is a rapid acting human insulin analog biosimilar to NovoLog (insulin aspart) indicated to improve glycemic...
- Xbryk Xbryk (denosumab-dssb) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...
- Ospomyv Ospomyv (denosumab-dssb) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
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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