Blog
RSS FeedPosted by Michael Wonder on 25 Jun 2019
Krystal Biotech receives regenerative medicine advanced therapy designation from FDA for KB103
24 June 2019 - RMAT designation granted to KB103 based on positive interim data from GEM-1 and GEM-2 study. ...
Posted by Michael Wonder on 25 Jun 2019
Ipsen announces U.S. FDA approval for newly designed pre-filled syringe for Somatuline Depot (lanreotide)
24 June 2019 - New syringe designed to help enhance injection experience. ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 24 Jun 2019
The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies
24 June 2019 - The FDA made a mistake Friday by approving a new drug called Vyleesi for women with ...
Posted by Michael Wonder on 24 Jun 2019
Correvio resubmits Brinavess (vernakalant) new drug application to U.S. FDA for the treatment of patients with recent onset atrial fibrillation
24 June 2019 - Correvio Pharma today announced it has resubmitted a new drug application to the U.S. FDA seeking approval ...
Posted 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 ...