Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2018
Paratek completes submission of new drug applications to U.S. FDA for oral and intravenous omadacycline for pneumonia and skin infections
5 February 2018 - Paratek Pharmaceuticals announced today that on February 2, 2018, it completed the submission of two new drug ...
Posted by Michael Wonder on 05 Feb 2018
Ferring's Zomacton (somatropin) for injection receives FDA approval to treat growth hormone deficiency in adults
31 January 2018 - Ferring expands U.S. endocrinology portfolio. ...
Posted by Michael Wonder on 05 Feb 2018
Capricor receives FDA regenerative medicine advanced therapy designation for Duchenne muscular dystrophy therapy
5 February 2018 - CAP-1002 to benefit from expedited review program for drugs for unmet needs. ...
Posted by Michael Wonder on 05 Feb 2018
AMAG Pharmaceuticals announces FDA approval of supplemental new drug application for Feraheme (ferumoxytol injection)
5 February 2018 - Feraheme is now a treatment option for all eligible adult patients with iron deficiency anaemia. ...
Posted by Michael Wonder on 04 Feb 2018
The Health 202: How 'Right to Try' caught Washington's eye
1 February 2018 - Of 7,267 bills proposed by members of Congress over the past year, President Trump mentioned just ...
Posted by Michael Wonder on 04 Feb 2018
Alnylam announces FDA acceptance of new drug application and priority review status for patisiran, an investigational RNAi therapeutic for the treatment of hereditary ATTR amyloidosis
1 February 2018 - PDUFA date set for 11 August 2018. ...
Posted by Michael Wonder on 02 Feb 2018
Protalix BioTherapeutics’ pegunigalsidase alfa receives fast track designation from the U.S. FDA
31 January 2018 - Fast Track designation highlights high unmet medical need in the treatment of Fabry disease. ...
Posted by Michael Wonder on 02 Feb 2018
FDA approves Avycaz (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 February 2018 - First gram-negative antibiotic approved in the U.S. to treat HABP/VABP in over 15 years. ...
Posted by Michael Wonder on 31 Jan 2018
Trump urges U.S. Congress to back 'right to try' for terminally ill
31 January 2018 - President Donald Trump said in his State of the Union address to the U.S. Congress on Tuesday ...
Posted by Michael Wonder on 31 Jan 2018
Alkermes submits new drug application to U.S. FDA for ALKS 5461 for the adjunctive treatment of major depressive disorder
31 January 2018 - New medicine for treating major depressive disorder supported by comprehensive efficacy and safety data package from ...
Posted by Michael Wonder on 31 Jan 2018
New drugs, but slow access — here's how to speed breakthroughs to patients
30 January 2018 - The U.S. FDA approved 46 novel drugs in 2017, a 21-year high. However, it could take ...
Posted by Michael Wonder on 30 Jan 2018
Theravance Biopharma and Mylan announce FDA acceptance of new drug application for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
29 January 2018 - FDA assigns PDUFA target action date of 13 November 2018. ...
Posted by Michael Wonder on 30 Jan 2018
Takeda's Zika vaccine gets U.S. FDA's 'fast track' status
30 January 2018 - Japan’s Takeda Pharmaceutical Co Ltd said on Monday the U.S. FDA had granted ‘fast track’ status to ...
Posted by Michael Wonder on 30 Jan 2018
FDA has to explain why Amgen was denied a key marketing incentive
30 January 2018 - Did the FDA treat Amgen differently than Johnson & Johnson when reviewing applications for their drugs? ...
Posted by Michael Wonder on 30 Jan 2018
Aradigm receives complete response letter from the FDA for Linhaliq NDA
29 January 2018 - Aradigm today announces that it received a complete response letter from the US FDA regarding its new ...