FDA

AstraZeneca recently has announced the results of the clinical trials POSEIDON which included the study of a combination of drugs Imfinzi (durvalumab) and tremelimumab with chemotherapy in lung cancer. Imfinzi is a human monoclonal antibody which blocks the interaction of PD-L1 with PD-1 by binding itself with ...

The US FDA today has given its nod to Trikafta (elexacaftor/ivacaftor/tezacaftor) of Vertex Pharmaceuticals, the first of its kind triple combination therapy for the patients with cystic fibrosis. The drug, Trikafta, has been approved for patients of age 12 years and older who have at least one F508del mutation...

The US FDA has approved Rybelsus (semaglutide) oral tablets to improve blood sugar in adult patients with Type II Diabetes. Rybelsus is an oral glucagon-like peptide (GLP-1) receptor protein treatment which has been approved after 15 years of the approval first GLP-1 agonist. GLP-1 is a hormone found in insuffi...

Peanut allergies (PA) are the most common and severe type of food allergies in children. Even a small fragment of this legume to an allergic person can result in permanent brain damage.  The prevalence rate of the Peanut allergy, over the past two decades, has tripled. According to DelveInsight, total prevalen...

The US FDA has in a recent move granted Roche’s Gazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis. Gazyva (obinutuzumab) is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Classified as a "monoclonal antibody", Gazyva is a CD20-directed cytolytic antibody. The drug...

Recently the U.S. Food and Drug Administration has recommended the use of Ibsrela (tenapanor), for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. A 50 mg, twice daily oral pill, Ibsrela is a small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen...

Daiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW). DS-8201 [fam-] trastuzumab deruxtecan), is an investigational antibody-drug conjugate (ADC) designed to deliver cytotoxic chemotherapy to cancer cells via a human epiderma...

Recently, the US FDA has approved a new drug therapy to treat adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. Ofev (nintedanib) capsules, the drug developed by Boehringer Ingelheim Pharmaceuticals, has shown efficacy in slowing down the rate of decline in pul...

FDA urges Pharma giants to increase their inclusion of men in new Breast Cancer trials The recent FDA recommendations have urged the Pharma companies for the inclusion of men in the clinical trials to test new breast cancer drugs. Men rarely develop Breast cancer. Less than 1% of men develop Breast cancer. And 1...

Vesselon Acquires FDA-Approved lipid microsphere drug Imagent Vesselon, an oncology therapeutics company, today acquired an FDA-approved drug Imagent for diagnostic purposes as a contrast agent for diagnostic ultrasound. Vesselon’s Vascular Encapsulation Sonication Targeting (VESTTM) system incorporates three FD...