Browse News
Filter News
Found 196 articles
-
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
-
Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator.
-
With Wednesday’s readout showing symptom improvements in obstructive sleep apnea patients, Eli Lilly is preparing to file for a label expansion for its blockbuster weight-loss drug Zepbound.
-
NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity
4/17/2024
NeuroBo Pharmaceuticals, Inc. today announced dosing of the first patient in the single ascending dose (SAD) Part 1 of its two-part Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.
-
Tirzepatide reduced sleep apnea severity by up to nearly two-thirds in adults with obstructive sleep apnea (OSA) and obesity
4/17/2024
Eli Lilly and Company announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection significantly reduced the apnea-hypopnea index compared to placebo, achieving the primary endpoints.
-
Florida District Judge Roy Altman earlier this week ruled against Eli Lilly, finding that the drugmaker cannot use state law to block reformulated versions of its blockbuster weight-loss and diabetes medication tirzepatide.
-
Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity
4/11/2024
Lipocine Inc., a biopharmaceutical company, announced results from a Phase 2 clinical trial which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant.
-
A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.
-
AMRA Medical’s Innovative Fat Z-Score Biomarkers Show Tirzepatide Treatment is Associated with a Potential Targeted Effect on Visceral Fat and Liver Fat
4/10/2024
Researchers from AMRA Medical, a leading health informatics company providing body composition analysis through magnetic resonance imaging (MRI), together with Eli Lilly, and researchers from Nantes Université, University Hospitals Cleveland, and Linköping University used visceral-, subcutaneous-, and liver fat z-scores derived from MRI to investigate changes in fat distribution patterns in patients with type 2 diabetes (T2D) participating in SURPASS-3 MRI.
-
As part of its ongoing review, the European Medicines Agency this week is slated to examine the potential risks of suicidal ideation and self-harm associated with diabetes and weight-loss treatments.
-
BioAge Appoints Renowned Cardiologist and Biopharma Entrepreneur Michael H. Davidson, MD, to its Board of Directors
4/9/2024
BioAge Labs, Inc. today announced the appointment of Michael Davidson, MD to the company's board of directors.
-
The four highest doses of Eli Lilly’s blockbuster diabetes treatment Mounjaro will be in short supply through the rest of the month due to strong demand, according to the regulator.
-
Now in Phase III with its small molecule orforglipron, Eli Lilly is leading the oral GLP-1 race against Novo Nordisk, Pfizer, Roche and others.
-
Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs.
-
Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs
4/1/2024
Fractyl Health, Inc. announced U.S. Food and Drug Administration approval of a pivotal Investigational Device Exemption to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist drug therapy, addressing a key unmet need in the treatment of obesity.
-
NeuroBo Pharmaceuticals Reports Year End 2023 Financial Results and Provides Corporate Update
3/28/2024
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2023 and provided a corporate strategic update.
-
The early-stage study showed that Viking Therapeutics’ oral obesity candidate VK2735, a dual agonist of the GLP-1 and GIP receptors, elicited a 3.3% reduction in mean body weight. The company plans to start a Phase II trial.
-
Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Oral Tablet Formulation of Dual GLP-1/GIP Receptor Agonist VK2735
3/26/2024
Viking Therapeutics, Inc. announced positive results from the company's Phase 1 multiple ascending dose clinical trial of an oral tablet formulation of VK2735, a dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors, in development for the potential treatment of metabolic disorders such as obesity.
-
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
-
Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease.