Blog
RSS FeedPosted by Michael Wonder on 01 Oct 2018
Congratulations. Your study went nowhere.
23 September 2018 - Researchers should embrace negative results instead of accentuating the positive, which is one of several biases that ...
Posted by Michael Wonder on 01 Oct 2018
Adamis Pharmaceuticals receives FDA approval for its lower dose Symjepi product
27 September 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has approved Adamis’ lower dose version (0.15 ...
Posted by Michael Wonder on 01 Oct 2018
HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating primary sclerosing cholangitis
27 September 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...
Posted by Michael Wonder on 01 Oct 2018
Intra-Cellular Therapies completes submission of new drug application for lumateperone for treatment of schizophrenia
28 September 2018 - Intra-Cellular Therapies today announced that the company has completed the rolling submission of its new drug application ...
Posted by Michael Wonder on 01 Oct 2018
FDA approves Genentech's Xolair (omalizumab) pre-filled syringe formulation
28 September 2018 - The 75 mg/0.5 mL and 150 mg/1 mL single-dose pre-filled syringes are expected to be available by ...
Posted by Michael Wonder on 01 Oct 2018
Fycompa newly approved by U.S. FDA as treatment for partial-onset seizures in paediatric patients with epilepsy
1 October 2018 - Eisai announced today that its U.S. subsidiary has received approval from the U.S. FDA for an ...
Posted by Michael Wonder on 28 Sep 2018
FDA approves first treatment for advanced form of the second most common skin cancer
28 September 2018 - New drug targets PD-1 pathway. ...
Posted by Michael Wonder on 28 Sep 2018
FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukaemia or multiple myeloma
28 September 2018 - Today the U.S. FDA permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual ...
Posted by Michael Wonder on 28 Sep 2018
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
28 September 2018 - First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Anti-fungal Drugs, instituted to spur ...
Posted by Michael Wonder on 28 Sep 2018
Eli Lilly migraine drug approved and will be free to patients
28 September 2018 - Amgen, Teva already launched new drugs called CGRP inhibitors. ...
Posted by Michael Wonder on 28 Sep 2018
CDER conversation: complex innovative trial designs
25 September 2018 - Complex innovative trial designs – including the use of adaptive, Bayesian, and other novel statistical approaches ...
Posted by Michael Wonder on 28 Sep 2018
U.S. FDA approves Vizimpro (dacomitinib) for the first-line treatment of patients with EGFR mutated metastatic non-small cell lung cancer
27 September 2018 - Approval supported by data from Phase 3 head-to-head study versus gefitinib. ...
Posted by Michael Wonder on 28 Sep 2018
Lilly's Emgality (galcanezumab-gnlm) receives U.S. FDA approval for the preventive treatment of migraine in adults
27 September 2018 - Eli Lilly announced today that the U.S. FDA has approved Emgality (galcanezumab-gnlm) 120 mg injection for the ...
Posted by Michael Wonder on 27 Sep 2018
Samsung Bioepis’ biologics license application for SB5 adalimumab biosimilar candidate accepted for review by the U.S. FDA
27 September 2018 - The biologics license application for SB5 was based on a 52 week Phase 3 study comparing SB5 ...
Posted by Michael Wonder on 27 Sep 2018
Statement by FDA Commissioner on preparations for the upcoming flu season and vaccinations
27 September 2018 - This week marks the official start of “flu season” for 2018-2019. ...