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RSS FeedPosted by Michael Wonder on 11 Jul 2019
Horizon Therapeutics submits teprotumumab biologics license application for the treatment of active thyroid eye disease
10 July 2019 - Horizon Therapeutics announced today that it has submitted a biologics license application to the U.S. FDA ...
Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
Posted by Michael Wonder on 10 Jul 2019
A Supreme Court ruling may have made it harder to get some info from the FDA
9 July 2019 - Anyone seeking certain information about a medicine from the FDA may have a harder time getting ...
Posted by Michael Wonder on 10 Jul 2019
U.S. appeals court signals sympathy to bid to strike down Obamacare
9 July 2019 - A federal appeals court panel appeared sympathetic on Tuesday to Republican efforts to overturn Obamacare, expressing skepticism ...
Posted by Michael Wonder on 10 Jul 2019
Novartis launches Adamis allergy shots in U.S. pharmacies amid EpiPen shortage
9 July 2019 - A unit of Novartis said on Tuesday it would make partner Adamis Pharmaceuticals Corp’s emergency allergy ...
Posted by Michael Wonder on 10 Jul 2019
FDA approves Katerzia, the first and only amlodipine oral suspension for paediatric patients 6 years of age and older
10 July 2019 - Azurity Pharmaceuticals announced today that the U.S. FDA has approved Katerzia (amlodipine) 1 mg/mL oral suspension, ...
Posted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...
Posted by Michael Wonder on 10 Jul 2019
Cellectar receives FDA fast track designation for CLR 131 in diffuse large B-cell lymphoma
9 July 2019 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in relapsed ...
Posted by Michael Wonder on 09 Jul 2019
ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice
9 July 2019 - The long-acting injectable regimen has been granted priority review status by the FDA, with a target approval ...
Posted by Michael Wonder on 09 Jul 2019
FDA accepts Merck’s supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule for melanoma and multiple other indications
9 July 2019 - Merck today announced that the U.S. FDA has accepted for review six supplemental biologics license applications to ...
Posted by Michael Wonder on 09 Jul 2019
FDA leverages private sector technology-based tools in its embrace of real world evidence
9 July 2019 - Following decades of near total reliance on randomised clinical trial data, the U.S. FDA (with a ...
Posted by Michael Wonder on 09 Jul 2019
Pharma giant using loophole to falsely promote opioid pain relief product across Australia
10 July 2019 - Debbie Thompson is a grandmother of five who likes to crochet in her spare time. The ...
Posted by Michael Wonder on 09 Jul 2019
The fragility of phase 3 trials supporting FDA approved anti-cancer medicines: a retrospective analysis
8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in ...
Posted by Michael Wonder on 09 Jul 2019
FDA to speed review of generic versions of opioid overdose antidote
8 July 2019 - The US FDA on Monday said it would prioritise and expedite the review of generic versions ...
Posted by Michael Wonder on 09 Jul 2019
Trump rule requiring drug prices in TV ads blocked
8 July 2019 - Federal judge sides with companies, saying regulation would violate free speech. ...