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RSS FeedPosted by Michael Wonder on 25 Aug 2020
FDA accepts filing of new drug application for tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations
25 August 2020 - Tepotinib granted priority review and is being evaluated under FDA Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 25 Aug 2020
Trump deadline for drug pricing order passes with no action
25 August 2020 - A deadline set by President Trump for moving forward with an executive order to lower drug ...
Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
Posted by Michael Wonder on 25 Aug 2020
Recruitment begins to fill up to seven non-executive roles on the NICE board
25 August 2020 - Roles will contribute to the development of the NICE’s strategic objectives. ...
Posted by Michael Wonder on 25 Aug 2020
As COVID-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
24 August 2020 - Stephen Hahn, a political novice who moved here in December to take over the FDA, has ...
Posted by Michael Wonder on 25 Aug 2020
Why are Trump and the Republicans so afraid of competition when it comes to drug prices?
24 August 2020 - President Trump recently signed two executive orders directly related to prescription drug prices in the U.S. ...
Posted by Michael Wonder on 25 Aug 2020
Over 200 medical professionals launch petition calling for better medication for bowel disease
24 August 2020 - A petition has been launched by over 200 medical professionals calling on PHARMAC to urgently fund ...
Posted by Michael Wonder on 25 Aug 2020
Turning Point Therapeutics granted fast-track designation for repotrectinib in NTRK positive TKI pre-treated advanced solid tumours
24 August 2020 - Turning Point Therapeutics today announced the FDA granted a third fast-track designation to its lead drug ...
Posted by Michael Wonder on 24 Aug 2020
Why an Amazon and Airbnb vet joined a digital health company that wants to slash drug prices
24 August 2020 - Geoffrey and Matt Chaiken have an ambitious plan to lower the price that consumers have to ...
Posted by Michael Wonder on 24 Aug 2020
FDA approves new Kyprolis (carfilzomib) combination regimen with Darzalex (daratumumab) and dexamethasone in both once- and twice-weekly dosing regimens
20 August 2020 - Approval based on the CANDOR and EQUULEUS studies in patients with relapsed/refractory multiple myeloma. ...
Posted by Michael Wonder on 24 Aug 2020
Exelixis announces submission of supplemental new drug application to U.S. FDA for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) for advanced renal cell carcinoma
24 August 2020 - Submission based on the phase 3 pivotal CheckMate-9ER trial, which met its primary endpoint of significantly improving ...
Posted by Michael Wonder on 24 Aug 2020
Tricida receives complete response letter from the FDA for its new drug application for veverimer for the treatment of metabolic acidosis and slowing of kidney disease progression in patients with metabolic acidosis associated with CKD
24 August 2020 - Tricida announced today that it received a complete response letter from the U.S. FDA for its new ...
Posted by Michael Wonder on 24 Aug 2020
EMA goes all-virtual for remainder of 2020
20 August 2020 - The EMA has announced that all its committee and working party meetings will be held virtually ...
Posted by Michael Wonder on 24 Aug 2020
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis in people ages 12 years and older
21 August 2020 - For the first time, up to 10,000 people in Europe ages 12 years and older with one ...
Posted by Michael Wonder on 23 Aug 2020
Prostate cancer treatment Nubeqa made available for free in Australia by Bayer
23 August 2020 - Prostate cancer kills more than 3,000 men a year in Australia. But now many will have access ...