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RSS FeedPosted by Michael Wonder on 31 Jul 2019
U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer
31 July 2019 - Darolutamide was approved in the U.S. under the FDA priority review designation; approval granted three months ahead ...
Posted by Michael Wonder on 26 Jul 2019
FDA approves Feraccru with a broad label of treating iron deficiency in adults
26 July 2019 - Feraccru to be marketed as Accrufer in the USA. ...
Posted by Michael Wonder on 25 Jul 2019
Aptar’s nasal unidose device approved by US FDA for first needle-free rescue treatment for severe hypoglycaemia
25 July 2019 - AptarGroup today announced that its Unidose Powder System was recently approved by the U.S. FDA for an ...
Posted by Michael Wonder on 24 Jul 2019
FDA approves Pfizer's biosimilar Ruxience (rituximab-pvvr), for certain cancers and auto-immune conditions
23 July 2019 - Pfizer today announced the United States FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), ...
Posted by Michael Wonder on 24 Jul 2019
FDA approves first treatment for severe hypoglycaemia that can be administered without an injection
24 July 2019 - The U.S. FDA today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment ...
Posted by Michael Wonder on 23 Jul 2019
U.S. District Court orders FDA to reconsider application for final approval of Brixadi (buprenorphine) extended release injection for the treatment of opioid use disorder
23 July 2019 - The U.S. District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating ...
Posted by Michael Wonder on 23 Jul 2019
Imfinzi (durvalumab) US label updated with overall survival data in unresectable, Stage III non-small cell lung cancer
22 July 2019 - Imfinzi is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy. ...
Posted by Michael Wonder on 23 Jul 2019
Baxter announces U.S. FDA approval of Myxredlin, the first and only ready-to-use insulin for IV infusion
22 July 2019 - Offers extended shelf life of 30 days at room temperature or 24 months refrigerated. ...
Posted by Michael Wonder on 22 Jul 2019
FDA approves first generics of Lyrica
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
Posted by Michael Wonder on 20 Jul 2019
Biohaven's Nurtec (riluzole) 505(B)2 application for amyotrophic lateral sclerosis affected by issues related to Apotex plant: complete response letter received from FDA
20 July 2019 - FDA cited issues with the active pharmaceutical ingredient used in the Biohaven 2017 bioequivalence study that was ...
Posted by Michael Wonder on 20 Jul 2019
FDA approves Otezla (apremilast) for the treatment of oral ulcers associated with Behçet’s disease
19 July 2019 - With this third indication in the US, Otezla is the first and only treatment approved for oral ...
Posted by Michael Wonder on 19 Jul 2019
Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia?
18 July 2019 - In late 2017, the FDA approved the first so-called smart pill, ushering in a new era ...
Posted by Michael Wonder on 17 Jul 2019
FDA approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available
17 July 2019 - Merck today announced that the U.S. FDA has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, 1.25 ...
Posted by Michael Wonder on 15 Jul 2019
FDA approves Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac magnetic resonance imaging in adult patients with known or suspected coronary artery disease
15 July 2019 - Coronary artery disease is an important public health issue-- a disease that affects 16.5 million Americans. ...
Posted by Michael Wonder on 15 Jul 2019
Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder
15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...