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RSS FeedPosted by Michael Wonder on 20 Oct 2021
CMS grants transitional pass through payment for Carlsmed's aprevo personalized interbody device
19 October 2021 - -Carlsmed announced today that CMS has granted aprevo a transitional pass through payment as part of the ...
Posted by Michael Wonder on 19 Oct 2021
Akero Therapeutics receives FDA fast track designation for efruxifermin for the treatment of NASH
19 October 2021 - Akero Therapeutics today announced that the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 19 Oct 2021
Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. FDA
19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 ...
Posted by Michael Wonder on 19 Oct 2021
Democrats’ drug pricing reforms aren’t what they seem
19 October 2021 - As part of their spending bill, Congressional Democrats are advancing legislation that'll empower Medicare to "negotiate" ...
Posted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...
Posted by Michael Wonder on 18 Oct 2021
U.S. Food and Drug Administration approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 18 Oct 2021
United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application
18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning. ...
Posted by Michael Wonder on 18 Oct 2021
Omeros receives complete response letter from FDA for biologics license application for narsoplimab in the treatment of HSCT-TMA
18 October 2021 - Omeros Corporation today announced that the company received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 18 Oct 2021
Revance provides regulatory update on daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar (frown) lines
15 October 2021 - Revance Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 18 Oct 2021
Oyster Point Pharma announces FDA approval of Tyrvaya (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry eye disease
18 October 2021 - Tyrvaya is the first and only nasal spray approved for the treatment of the signs and symptoms ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves naloxone injection to counteract opioid overdoses
18 October 2021 - The FDA has approved Zimhi (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ...
Posted by Michael Wonder on 18 Oct 2021
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
18 October 2021 - The U.S. FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. ...
Posted by Michael Wonder on 18 Oct 2021
Update on U.S. FDA review of biologics license application for bimekizumab
16 October 2021 - The U.S. FDA has informed UCB via letter that the Agency was unable to complete review of ...