FDA

Oct 04, 2019

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...

Sep 20, 2019

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...

Sep 18, 2019

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...

Sep 10, 2019

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...

Sep 09, 2019

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...

Aug 29, 2019

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...

Aug 08, 2019

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...

Aug 06, 2019

FDA approves first Tenosynovial giant cell tumour treatment Turalio (Pexidartinib) The US FDA has given its approval to Turalio (pexidartinib) capsules for the treatment of symptomatic tenosynovial giant cell tumour (TGCT) associated with severe morbidity or functional limitations that surgery has failed to impr...

Aug 02, 2019

Gastroparesis is a condition that affects the movement of the food in the stomach and intestines and causes distress leading to bloating, nausea, and heartburn. If the condition is due to Diabetes in the patients, it is called Diabetic Gastroparesis. According to the American Diabetes Association (ADA), Gastropares...

Aug 01, 2019

Bayer and Orion's Nubeqa gets FDA recommendations for Prostate Cancer The U.S. FDA has given its nod to Nubeqa (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa is a steroidal androgen receptor inhibitor (ARi), and its recommendation came afte...