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RSS FeedPosted by Michael Wonder on 24 Feb 2018
KemPharm announces FDA approval of Apadaz (benzhydrocodone and paracetamol) for the short-term management of acute pain
23 February 2018 - Apadaz is the first pro-drug of hydrocodone/paracetamol to be approved by FDA. ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 23 Feb 2018
Evofem Biosciences receives fast track designation for Amphora for prevention of Chlamydia
21 February 2018 - Evofem Biosciences today announced that the U.S. FDA has granted fast track designation for Amphora (L-lactic acid, ...
Posted by Michael Wonder on 22 Feb 2018
Developing anti-cancer drugs in orphan molecular entities — a paradigm under construction
22 February 2018 - Genomic characterisation of cancers has shown that some oncogenic alterations occur at very low frequency and are ...
Posted by Michael Wonder on 22 Feb 2018
Federal right-to-try legislation — threatening the FDA’s public health mission
22 February 2018 - A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. ...
Posted by Michael Wonder on 22 Feb 2018
FDA acceptance of Medicines360's filing for supplemental new drug application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg
22 February 2018 - Application seeks to extend duration of use up to 5 years for Liletta. ...
Posted by Michael Wonder on 21 Feb 2018
PTC Therapeutics receives formal dispute resolution request decision from the FDA's Office of New Drugs
20 February 2018 - PTC Therapeutics today announced that the Office of New Drugs of the U.S. FDA has reiterated ...
Posted by Michael Wonder on 21 Feb 2018
Trump pushing ahead on Koch-backed experimental drugs 'right to try' agenda
21 February 2018 - The Koch brothers have already backed efforts to pass similar legislation in 38 states. ...
Posted by Michael Wonder on 21 Feb 2018
Mylan receives tentative approval for combination HIV treatment DTG/FTC/TAF under FDA's PEPFAR program
20 February 2018 - Mylan's DTG/FTC/TAF will be the first TAF-based fixed-dose combination to be offered to patients in developing ...
Posted by Michael Wonder on 20 Feb 2018
Acorda announces FDA acceptance of new drug application for Inbrija (levodopa inhalation powder)
20 February 2018 - Acorda Therapeutics today announced that the U.S. FDA has accepted for filing its new drug application for ...
Posted by Michael Wonder on 19 Feb 2018
RMAT vs. breakthrough vs. fast track: companies seek clarity on FDA draft guidance
19 February 2018 - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, as well ...
Posted by Michael Wonder on 19 Feb 2018
FDA approves Osmotica Pharmaceutical’s once-daily Osmolex ER (amantadine) extended-release tablets for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adults
19 February 2018 - Osmotica Pharmaceutical announced today that the U.S. FDA has approved Osmolex ER, an amantadine extended release tablet, ...
Posted by Michael Wonder on 17 Feb 2018
Allecra Therapeutics announces fast track designation for lead antibiotic in resistant infections
14 February 2018 - Supports Allecra’s lead program in Phase 2 clinical trials to treat serious gram-negative infections. ...
Posted by Michael Wonder on 17 Feb 2018
Apricus Biosciences receives complete response letter from FDA for Vitaros
16 February 2018 - Company evaluating deficiencies and potential path forward. ...
Posted by Michael Wonder on 16 Feb 2018
FDA grants priority review for Genentech’s Rituxan (rituximab) for pemphigus vulgaris
13 February 2018 - The FDA previously granted breakthrough therapy designation and orphan drug designation for Rituxan in pemphigus vulgaris. ...