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RSS FeedPosted 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 24 Jan 2020
Ready for rescue – new nasally administered glucagon for severe hypoglycaemia available in Canada
23 January 2020 - Eli Lilly Canada introduces Baqsimi, another Canadian innovation to help manage diabetes complications. ...
Posted by Michael Wonder on 24 Jan 2020
HLS Therapeutics files new drug submission for Perseris in Canada
23 January 2020 - If approved by Health Canada, Perseris would become the first once-monthly risperidone long-acting injectable used in the ...
Posted by Michael Wonder on 24 Jan 2020
Health Canada approves Keytruda (pembrolizumab) as first-line treatment for patients with advanced renal cell carcinoma
23 January 2020 - Approval based on results of KEYNOTE-426, Where Keytruda in combination with axitinib reduced the risk of death ...
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
Hunt denies helping Liberal donor push for regulator's review
23 January 2020 - Health Minister Greg Hunt has denied accusations he interfered in a regulator's decision on whether to ...
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
Court of Justice upholds EMA’s approach to transparency
22 January 2020 - EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and ...
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
Merck strengthens Gonal-f portfolio with approval for 150 IU pen in the European Union
22 January 2020 - New Gonal-f 150 IU pen provides additional flexibility and convenience at every stage of the patients’ stimulation ...
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. ...