Blog
RSS FeedPosted by Michael Wonder on 23 Mar 2019
FDA issues complete response letter for Zynquista (sotagliflozin)
22 March 2019 - The U.S. FDA issued a complete response letter regarding the New Drug Application for investigational Zynquista ...
Posted by Michael Wonder on 23 Mar 2019
FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases
22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development. ...
Posted by Michael Wonder on 23 Mar 2019
Recro Pharma receives complete response letter from the FDA for intravenous meloxicam
22 March 2019 - Recro Pharma today announced it has received a second complete response letter from the U.S. FDA Office ...
Posted by Michael Wonder on 23 Mar 2019
Genmab announces European regulatory submission for daratumumab in combination with lenalidomide and dexamethasone in frontline multiple myeloma
22 March 2019 - Type II variation application submitted to the EMA for daratumumab in combination with lenalidomide and dexamethasone as ...
Posted by Michael Wonder on 21 Mar 2019
Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations
21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...
Posted by Michael Wonder on 21 Mar 2019
Promoting biosimilars up to health plans, manufacturers, doctors, Gottlieb says
21 March 2019 - As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about ...
Posted by Michael Wonder on 21 Mar 2019
FDA approves new device for treating moderate to severe chronic heart failure in patients
21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...
Posted by Michael Wonder on 21 Mar 2019
AbbVie is sued for using Humira patent deals to block competition in the U.S.
20 March 2019 - In a novel step, a New York union accused AbbVie and seven other drug makers of ...
Posted by Michael Wonder on 21 Mar 2019
Jazz Pharmaceuticals announces U.S. FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
20 March 2019 - Sunosi is the first and only dual-acting dopamine and norepinephrine re-uptake inhibitor approved by the FDA to ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar groups offer proposals to help US better mirror EU successes
19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 20 Mar 2019
Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation
19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...
Posted by Michael Wonder on 20 Mar 2019
Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic
20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for ...
Posted by Michael Wonder on 20 Mar 2019
FDA reform: it’s time to act, but not as an independent agency
19 March 2019 - In a rare exercise in bipartisan leadership, former FDA commissioners of both political parties called, in ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves first treatment for post-partum depression
19 March 2019 - The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment ...