Found 1,466 articles
Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
VALBIOTIS SA: Valbiotis Presents the Full Results of the Phase II/III REVERSE-IT Study: Impressive Efficacy of TOTUM•63 Against Prediabetes and the Early Stages of Type 2 Diabetes, a First for a Non-drug Active Substance
Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible) announces the results of the international Phase II/III REVERSE-IT study, demonstrating TOTUM•63's impressive efficacy on key markers of glucose metabolism, with efficacy results comparable to those of some leading anti-diabetic drugs, in a similar population.
Dr. Reddy's Laboratories Announces its Launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S.
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced its launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S. market, a therapeutic equivalent generic version of KOMBIGLYZE® XR (saxagliptin and metformin hydrochloride extended release) tablets, approved by U. S. Food and Drug Administration (USFDA).
Lilly Reports Second-Quarter 2023 Financial Results, Highlights Accelerating Revenue Growth and Key Pipeline Advancements
Lilly defines New Products as select products launched since 2022, which currently consist of Jaypirca, Mounjaro and Omvoh.
Celmatix and Aché Laboratórios Announce Collaboration to Investigate a Novel Melatonin Receptor Agonists for Women’s Health
Celmatix Inc. and Aché Laboratórios, a leading Brazilian pharmaceutical company, announced a collaboration and license option agreement to jointly investigate a novel peripherally preferred melatonin receptor agonist, discovered by Aché, for Women's Health indications.
TheracosBio Announces Publication of Data on the Safety and Effectiveness of Brenzavvy™ (bexagliflozin) as an Adjunct to Metformin
TheracosBio today announced the publication of a study titled “ Bexagliflozin as an Adjunct to Metformin for the Treatment of Type 2 Diabetes in Adults: a 24-Week, Randomized, Double-Blind, Placebo-Controlled Trial ” in Diabetes, Obesity and Metabolism . The Phase 3 study assessed the safety and effectiveness of Brenzavvy™.
Fractyl Health Announces Clinical Update on Revita® Real World Registry in Germany and Launch of Revita+™ Telehealth Program Combining Behavioral Recommendations with Revita Treatment for Type 2 Diabetes
Fractyl Health Announces Clinical Update on Revita ® Real World Registry in Germany and Launch of Revita+ ™ Telehealth Program Combining Behavioral Recommendations with Revita Treatment for Type 2 Diabetes.
Merck, known as MSD outside the United States and Canada, announced financial results for the second quarter of 2023.
Capital Rx Launches Rx Reverse in Partnership with Virta Health to Combat Type 2 Diabetes and Obesity
Capital Rx, the health technology company changing the way prescription drugs are priced and patients are cared for, and type 2 diabetes reversal leader Virta Health have partnered to introduce Rx Reverse.
TheracosBio Announces Commercial Availability of Brenzavvy™ (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes
TheracosBio announced that Brenzavvy™, an FDA-approved oral sodium-glucose cotransporter 2 inhibitor, is now available by prescription through the Mark Cuban Cost Plus Drug Company, PBC.
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.
US FDA approves Jardiance® (empagliflozin) for the treatment of type 2 diabetes in children 10 years and older
The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
Enveda Biosciences, a biotechnology company discovering new medicines from natural sources, released the details of one of its foundational AI models, MS2Mol, in a pre-print posted on ChemRxiv.
Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes.
Novo Nordisk to present 26 abstracts showcasing cardiometabolic leadership and long-standing innovation at the 83rd Annual American Diabetes Association Scientific Sessions
Novo Nordisk announced the presentation of 26 abstracts highlighting the breadth of its approved and investigational medicines at the upcoming 83rd Annual Scientific Sessions of the American Diabetes Association.
Curative Biotechnology Announces Establishment of Japanese Subsidiary for Licensing Transactions and Asset Acquisitions
Curative Biotechnology Inc., a development-stage biomedical company focused on novel therapies for rare diseases and conditions, announced that the registration process has begun for the creation of a subsidiary in Japan with an official incorporation date expected August 1, 2023, to facilitate licensing transactions and asset licensing within the country.
Glyscend Therapeutics Announces Positive Topline Phase 2a Clinical Results and Progress with GLY-200, a First-in-Class Treatment for Type 2 Diabetes and Obesity
Glyscend Therapeutics, a clinical-stage biotechnology company pioneering a new generation of orally administered first-in-class gut-targeted polymer therapies, today announced clinical progress with its lead candidate, GLY-200, for the treatment of type 2 diabetes (T2D) and obesity.
Curative Biotechnology Inc. announced that a Patent Cooperation Treaty application was duly filed in the U.S. Receiving Office on May 22, 2023, claiming priority to U.S. Provisional Application No. 63/345,759, filed May 25, 2022.
JAMP Pharma Group receives Health Canada approval for PrJAMP Dapagliflozin, a new generic alternative for the treatment of type 2 diabetes
The JAMP Pharma Group is pleased to announce the launch of PrJAMP Dapagliflozin, a generic alternative to the reference product Forxiga® d'Astrazeneca Canada Inc.
Lilly Reports First-Quarter 2023 Financial Results, Highlights Continued Core Business Growth and Pipeline Momentum
Lilly defines New Products as select products launched since 2022, which currently consist of Jaypirca and Mounjaro.