Blog
RSS FeedPosted by Michael Wonder on 24 Jun 2019
How big pharma suppresses ‘biosimilars’
23 June 2019 - Deals with insurers and pharmacy benefit managers at patient and taxpayer expense. ...
Posted by Michael Wonder on 23 Jun 2019
Statement on agency’s efforts to increase transparency in medical device reporting
21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...
Posted by Michael Wonder on 23 Jun 2019
FDA issues complete response letter for Ryaltris (olopatadine hydrochloride and mometasone furoate)
22 June 2019 - We would like to inform you that the U.S. FDA has issued a complete response letter ...
Posted by Michael Wonder on 23 Jun 2019
At least three people in running to head FDA
21 June 2019 - Acting head Norman Sharpless seeks the position, but a Harvard medical center chief executive is also under ...
Posted by Michael Wonder on 22 Jun 2019
FDA declines to approve Daiichi Sankyo's blood cancer treatment
21 June 2019 - Japan’s Daiichi Sankyo Co said on Friday the U.S. FDA has declined to approve its drug ...
Posted by Michael Wonder on 22 Jun 2019
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone intracanalicular insert for ophthalmic use) for the treatment of ocular inflammation following ophthalmic surgery
21 June 2019 - Dextenza now approved for the treatment of ocular inflammation and pain following ophthalmic surgery. ...
Posted by Michael Wonder on 22 Jun 2019
Should the FDA speed up or slow down approval of new cancer drugs?
21 June 2019 - Earlier this month, the FDA announced the creation of Project Facilitate. ...
Posted by Michael Wonder on 22 Jun 2019
FDA approves Botox (onabotulinumtoxinA) for paediatric patients with upper limb spasticity
21 June 2019 - Approval marks 10th Botox therapeutic indication in its 30th anniversary year. ...
Posted by Michael Wonder on 22 Jun 2019
FDA approves new treatment for hypoactive sexual desire disorder in pre-menopausal women
21 June 2019 - The U.S. FDA today approved Vyleesi (bremelanotide) to treat acquired, generalised hypoactive sexual desire disorder in pre-menopausal ...
Posted by Michael Wonder on 21 Jun 2019
FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
21 June 2019 - The U.S. FDA today expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of ...
Posted by Michael Wonder on 20 Jun 2019
Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics
20 June 2019 - Addressing the crisis of opioid addiction is an issue of great concern for our nation and remains ...
Posted by Michael Wonder on 20 Jun 2019
Pathway to US approval clarified after FDA issues complete response letter on use of Bronchitol for adult CF patients
20 June 2019 - Pharmaxis today announced its US licensee Chiesi has received a complete response letter from the US ...
Posted by Michael Wonder on 20 Jun 2019
U.S. FDA accepts supplemental biologics license application for Ultomiris (ravulizumab-cwvz) under priority review for the treatment of atypical haemolytic uremic syndrome
20 June 2019 - FDA sets target action date of 19 October 2019. ...
Posted by Michael Wonder on 20 Jun 2019
Sustainable discovery and development of antibiotics — is a non-profit approach the future?
19 June 2019 - Shifting to a nonprofit-driven model for development of antibiotics could encourage discovery and development of truly needed ...
Posted by Michael Wonder on 19 Jun 2019
Melinta Therapeutics announces U.S. FDA acceptance of supplemental new drug application for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia
19 June 2019 - Application seeks to expand label to include an indication and phase III data for the treatment of ...