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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Alnylam receives positive reimbursement recommendation from the CADTH for use of Givlaari for the treatment of acute hepatic porphyria in adults

18 October 2021 - Givlaari reduces chronic pain, improves quality of life and is the first and only therapy proven ...

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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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EMA grants PRIME designation for JR-141 for the treatment of mucopolysaccharidosis type II (Hunter syndrome)

18 October 2021 - JCR Pharmaceuticals announced today that the EMA has granted PRIME designation for the investigational drug JR-141 (pabinafusp ...

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Australia secures additional COVID-19 treatments

17 October 2021 - The Australian Government has secured access to two additional COVID-19 treatments to support the National Plan to ...

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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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NICE approves Ofev for PF-ILD

18 October 2021 - NICE has recommended Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of adult patients with chronic fibrosing ...

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New asthma drug approved on NHS branded a ‘wonder drug’

18 October 2021 - NICE has issued a Final Appraisal Determination recommending dupilumab as an add-on maintenance treatment for severe ...

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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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TGA provisional approval of Roche COVID-19 treatment, casirivimab with imdevimab (Ronapreve)

18 October 2021 - The TGA has provisionally approved the use of the Roche combination therapy, casirivimab + imdevimab (Ronapreve) ...

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