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RSS FeedPosted by Michael Wonder on 14 Feb 2019
Harmony Biosciences announces file acceptance of its new drug application for pitolisant
12 February 2019 - FDA grants priority review of the pitolisant new drug application. ...
Posted by Michael Wonder on 14 Feb 2019
DBV Technologies provides update on regulatory status of Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age
13 February 2019 - Progress made to date to enable resubmission in Q3 2019. ...
Posted by Michael Wonder on 14 Feb 2019
Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease
13 February 2019 - Egaten is the only drug approved in the US for the treatment of people with fascioliasis and ...
Posted by Michael Wonder on 13 Feb 2019
Statement from FDA Commissioner on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs
13 February 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. ...
Posted by Michael Wonder on 13 Feb 2019
Industry lauds FDA RWE framework, calls for tweaks
12 February 2019 - The US FDA regulatory framework for the use of real-world evidence drew positive reactions from biopharma ...
Posted by Michael Wonder on 13 Feb 2019
Lynparza (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer
28 January 2016 - AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for the oral poly ...
Posted by Michael Wonder on 13 Feb 2019
Mylan launches Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), at a list price 70% less than the brand
12 February 2019 - Unique pricing of Wixela Inhub immediately benefits patients and reduces overall cost to the U.S. health care ...
Posted by Michael Wonder on 13 Feb 2019
Genmab announces U.S. FDA approval of Darzalex (daratumumab) split dosing regimen
12 February 2019 - Provides healthcare professionals with option to split first Darzalex infusion over two consecutive days. ...
Posted by Michael Wonder on 13 Feb 2019
Neurotech Pharmaceuticals granted fast track designation from the US FDA for the treatment of macular telangiectasia type 2
12 February 2019 - Neurotech Pharmaceuticals announced today that the US FDA has granted fast track designation for the Company's development ...
Posted by Michael Wonder on 12 Feb 2019
Statement from FDA Commissioner on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic
12 February 2019 - The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. ...
Posted by Michael Wonder on 12 Feb 2019
Catalyst Pharma sees net price of drug, once free, topping $300,000
12 February 2019 - Catalyst Pharmaceuticals said on Monday that it expects its drug for a rare disease, which had ...
Posted by Michael Wonder on 11 Feb 2019
FDA accepts sBLA and grants priority review for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
11 February 2019 - Merck and Pfizer today announced that the US FDA has accepted for priority review the supplemental biologics ...
Posted by Michael Wonder on 11 Feb 2019
Apellis Pharmaceuticals’ APL-2 receives fast track designation from the FDA for the treatment of patients with paroxysmal nocturnal haemoglobinuria
11 February 2019 - New designation now includes all PNH patients. ...
Posted by Michael Wonder on 11 Feb 2019
‘One-and-done’ for new drugs could cut patent thickets and boost generic competition
11 February 2019 - In a perfect world, the system for conveying medications from their makers to patients should be ...
Posted by Michael Wonder on 11 Feb 2019
Clementia granted rare paediatric disease designation by FDA for palovarotene for fibrodysplasia ossificans progressiva
11 February 2019 - Clementia Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to palovarotene for ...