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RSS FeedPosted by Michael Wonder on 26 Mar 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia with an IDH1 mutation in adult patients ineligible for intensive chemotherapy
26 March 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) in ...
Posted by Michael Wonder on 26 Mar 2019
Novartis receives FDA approval for Mayzent (siponimod), the first oral drug to treat secondary progressive MS with active disease
26 March 2019 - Novartis today announced that the US FDA has approved Mayzent® (siponimod) for the treatment of adults with ...
Posted by Michael Wonder on 26 Mar 2019
Promedior received breakthrough therapy designation from FDA for PRM-151 in idiopathic pulmonary fibrosis
26 March 2019 - Promedior today announced that PRM-151, a novel investigational anti-fibrotic immunomodulator, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 26 Mar 2019
Celgene submits application to FDA for ozanimod for the treatment of relapsing forms of multiple sclerosis
25 March 2019 - Celgene Corporation today announced that the Company has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 24 Mar 2019
As political scrutiny mounts, Eli Lilly divulges new insulin pricing data
24 March 2019 - Lilly says the price it was paid for popular insulin Humalog fell 8.1% from 2014 to 2018 ...
Posted by Michael Wonder on 24 Mar 2019
Drug prices on TV? They may be coming.
23 March 2019 - The Trump administration is moving ahead with its proposal to require drug companies to disclose the ...
Posted by Michael Wonder on 23 Mar 2019
Drug company protections are latest stumbling block for NAFTA rewrite
21 March 2019 - President Trump’s ability to get his revised North American Free Trade Agreement through Congress may hinge ...
Posted 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22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development.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 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 ...