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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 ...
Posted by Michael Wonder on 18 Oct 2021
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 ...
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
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 ...
Posted by Michael Wonder on 18 Oct 2021
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 ...
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
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 ...
Posted by Michael Wonder on 18 Oct 2021
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 ...
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 ...
Posted by Michael Wonder on 18 Oct 2021
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) ...