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 ...

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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 ...

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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 ...

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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" ...

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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 ...

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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 ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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. ...

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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 ...

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