Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Jan 2020
FDA approves the first targeted therapy to treat a rare mutation in patients with gastro-intestinal stromal tumours
9 January 2020 - Today, the U.S. FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal ...
Posted by Michael Wonder on 09 Jan 2020
FDA real world evidence to be made available on Google Cloud
8 January 2020 - The company is making the agency's open-source MyStudies platform available, enabling for easier access to data for ...
Posted by Michael Wonder on 09 Jan 2020
Nabriva Therapeutics receives FDA acknowledgement of new drug application resubmission for intravenous Contepo (fosfomycin) for injection
8 January 2020 - PDUFA action date set for 19 June 2020. ...
Posted by Michael Wonder on 09 Jan 2020
U.S. FDA approves supplemental new drug application for expanded indication of Mycamine (micafungin for injection) for the treatment of invasive candidiasis in paediatric patients less than 4 months of age
8 January 2020 - Astellas Pharma today announced that the U.S. FDA has approved its supplemental new drug application for ...
Posted by Michael Wonder on 09 Jan 2020
Aruvant receives FDA rare paediatric disease designation for ARU-1801 for the treatment of sickle cell disease
8 January 2020 - ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and ...
Posted by Michael Wonder on 08 Jan 2020
Abuses of FDA regulatory procedures - the case of Suboxone
8 January 2020 - The manufacturer of brand-name buprenorphine products exploited various FDA regulatory procedures to impede market entry of generic ...
Posted by Michael Wonder on 08 Jan 2020
ReNetX Bio receives fast track designation from U.S. FDA
8 January 2020 - Potential first-in-class therapy for chronic spinal cord injury. ...
Posted by Michael Wonder on 08 Jan 2020
Why Humira’s price keeps rising despite FDA approval of generic competition
8 January 2020 - The FDA has approved five generic versions of Humira — the world’s biggest-selling drug with global ...
Posted by Michael Wonder on 08 Jan 2020
FDA is grappling with digital health regulation
8 January 2020 - The Food and Drug Administration announced this week it will hold a public meeting in late ...
Posted by Michael Wonder on 08 Jan 2020
FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer
8 January 2020 - On January 8, 2020, the Food and Drug Administration approved pembrolizumab (Keytruda) for the treatment of ...