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RSS FeedPosted by Michael Wonder on 14 Jan 2020
Chiasma announces FDA acceptance of Mycapssa new drug application resubmission
13 January 2020 - FDA sets PDUFA date of 26 June 2020. ...
Posted by Michael Wonder on 14 Jan 2020
Incidental imaging findings in clinical trials
13 January 2020 - Clinical trial end points are outcome measures used to assess the efficacy and safety of an ...
Posted by Michael Wonder on 14 Jan 2020
PTC Therapeutics provides corporate update
13 January 2020 - PTC-AADC MAA submitted; BLA now expected to be submitted in 2Q 2020. ...
Posted by Michael Wonder on 14 Jan 2020
Ultragenyx and Kyowa Kirin announce submission of supplemental biologics license application to U.S. FDA for Crysvita (burosumab) for tumour-induced osteomalacia
13 January 2020 - Ultragenyx and Kyowa Kirin today announced that they submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 13 Jan 2020
Imago receives fast track designation from U.S. FDA for bomedemstat for treatment of essential thrombocythemia
13 January 2020 - Imago BioScience today announced that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 13 Jan 2020
Neurelis announces FDA approval for seizure rescue treatment Valtoco (diazepam nasal spray) that incorporates the science of Intravail for consistent and reliable absoption
13 January 2020 - Valtoco is the first nasal spray approved by the FDA as a rescue treatment for people with ...
Posted by Michael Wonder on 13 Jan 2020
Lynparza regulatory submission granted priority review in the US for first-line maintenance treatment with bevacizumab in advanced ovarian cancer
13 January 2020 - Submission based on Phase III PAOLA-1 trial for patients with advanced ovarian cancer regardless of biomarker ...
Posted by Michael Wonder on 13 Jan 2020
Aquestive Therapeutics receives FDA response to Citizen’s Petition
12 January 2020 - Aquestive Therapeutics today reported that the U.S. FDA issued a response letter dated 10 January 2020 denying ...
Posted by Michael Wonder on 12 Jan 2020
The FDA is in trouble. Here’s how to fix it.
11 January 2020 - Some New Year’s resolutions for the incoming boss. ...
Posted by Michael Wonder on 12 Jan 2020
At 16, she’s a pioneer in the fight to cure sickle cell disease
11 January 2020 - Helen Obando is the youngest person ever to get a gene therapy that scientists hope will cure ...
Posted by Michael Wonder on 10 Jan 2020
Alnylam initiates rolling submission of new drug application to U.S. FDA for lumasiran for the treatment of primary hyperoxaluria type 1
10 January 2020 - Company plans to complete submission in early 2020. ...
Posted by Michael Wonder on 10 Jan 2020
Meissa Vaccines receives U.S. FDA fast track designation for respiratory syncytial virus vaccine, MV-012-968
10 January 2020 - Meissa Vaccines announced today that the U.S. FDA has granted fast track designation to MV-012-968, an ...
Posted by Michael Wonder on 10 Jan 2020
Eagle Pharmaceuticals resubmits NDA for Ryanodex for exertional heat stroke
9 January 2020 - Eagle Pharmaceuticals today announced that the Company has resubmitted its new drug application for Ryanodex (dantrolene sodium ...
Posted by Michael Wonder on 10 Jan 2020
Blueprint Medicines initiates rolling NDA submission to FDA for pralsetinib for the treatment of patients with RET fusion positive non-small cell lung cancer
8 January 2020 - Expect to complete NDA rolling submission for RET fusion-positive non-small cell lung cancer in Q1 2020. ...
Posted by Michael Wonder on 09 Jan 2020
Minoryx Therapeutics receives US FDA fast-track designation for leriglitazone in the treatment of X-ALD
9 January 2020 - Leriglitazone (MIN-102), a novel, brain penetrant, orally bioavailable and selective PPARγ agonist, is currently in late-stage development ...