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RSS FeedPosted by Michael Wonder on 28 Jan 2020
US FDA approves only triple-combination tablet with Jardiance for adults with type 2 diabetes
27 January 2020 - Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) is a once-daily therapy combining three well-established treatments in one ...
Posted by Michael Wonder on 28 Jan 2020
Genentech submits supplemental biologics license application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer
26 January 2020 - Application is being reviewed under FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 27 Jan 2020
FDA approves Merck’s Dificid (fidaxomicin) to treat Clostridioides difficile in children aged six months and older
27 January 2020 - Merck today announced the U.S. FDA has approved a new drug application for Dificid (fidaxomicin) for oral ...
Posted by Michael Wonder on 24 Jan 2020
FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
23 January 2020 - Today, the U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of ...
Posted by Michael Wonder on 23 Jan 2020
Baudax Bio announces PDUFA date for intravenous meloxicam
22 January 2020 - Baudax Bio today announced that the U.S. FDA has set a PDUFA goal date of 20 ...
Posted by Michael Wonder on 23 Jan 2020
Sick of high drug prices, insurers join hospitals to make their own generic medications
23 January 2020 - Everyone complains about high drug prices. But hospitals — and now insurers — are trying to ...
Posted by Michael Wonder on 23 Jan 2020
Jazz Pharmaceuticals submits new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy
22 January 2020 - Jazz Pharmaceuticals today announced the submission of a new drug application to the U.S. Food and Drug ...
Posted by Michael Wonder on 22 Jan 2020
Supernus announces FDA acceptance for review of new drug application for SPN-812 for the treatment of ADHD
21 January 2020 - PN-812 (viloxazine hydrochloride), a once-daily novel serotonin norepinephrine modulating agent, demonstrates a reduction in ADHD-RS-5 total score ...
Posted by Michael Wonder on 22 Jan 2020
The FDA continues to struggle with the implications of approving Sarepta’s drugs
22 January 2020 - New documents released Wednesday lay bare the stark divide within the Food and Drug Administration regarding ...
Posted by Michael Wonder on 22 Jan 2020
FDA accepts Evoke Pharma’s NDA resubmission for Gimoti
21 January 2020 - PDUFA Target Goal Date is 19 June 2020. ...
Posted by Michael Wonder on 21 Jan 2020
FDA approves first treatment for thyroid eye disease
21 January 2020 - Today, the U.S. FDA approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a ...
Posted by Michael Wonder on 21 Jan 2020
Old drug, new tricks: existing medicines show promise in fighting cancer
20 January 2020 - Dozens of compounds approved for other purposes can kill cancer cells selectively. ...
Posted by Michael Wonder on 21 Jan 2020
Genprex receives U.S. FDA fast track designation for gene therapy that targets lung cancer
21 January 2020 - Genprex today announced that the U.S FDA has granted fast track Designation for Genprex’s Oncoprex immunogene ...
Posted by Michael Wonder on 21 Jan 2020
US FDA grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
21 January 2020 - Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients. ...
Posted by Michael Wonder on 21 Jan 2020
The biosimilar solution to expensive cancer care
20 January 2020 - In a recent column in Evidence-Based Oncology, Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer ...