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RSS FeedPosted by Michael Wonder on 11 Mar 2023
Acadia Pharmaceuticals announces US FDA approval of Daybue (trofinetide) for the treatment of Rett syndrome in adult and paediatric patients two years of age and older
10 March 2023 - Company expects Daybue to be available by the end of April 2023. ...
Posted by Michael Wonder on 10 Mar 2023
Pfizer’s Zavzpret (zavegepant) migraine nasal spray receives FDA approval
10 March 2023 - Zavzpret is the first and only calcitonin gene-related peptide receptor antagonist nasal spray for the acute treatment ...
Posted by Michael Wonder on 08 Mar 2023
Amphastar Pharmaceuticals receives FDA approval for naloxone hydrochloride nasal spray 4 mg
8 March 2023 - Amphastar Pharmaceuticals announced that the US FDA has granted approval of its new drug application for ...
Posted by Michael Wonder on 07 Mar 2023
FDA grants Lenire tinnitus treatment device de novo approval
7 March 2023 - FDA approval based on results of 112 patient pivotal TENT-A3 clinical trial supported by confirmatory real world ...
Posted by Michael Wonder on 07 Mar 2023
Shorla Oncology announces US FDA approval of nelarabine injection for the treatment of T-cell leukaemia
7 March 2023 - Nelarabine injection ensures access to a lifesaving treatment that historically has been in shortage. ...
Posted by Michael Wonder on 06 Mar 2023
US FDA approves intramuscular administration for Merck’s MMRV family of vaccines: M-M-RII (measles, mumps and rubella virus vaccine live), Varivax (varicella virus vaccine live) and ProQuad (measles, mumps, rubella and varicella virus vaccine live)
6 March 2023 - With this additional route of administration, the MMRV family now joins other routinely recommended vaccines that ...
Posted by Michael Wonder on 06 Mar 2023
Roche receives FDA approval of label expansion for Ventana PD-L1 (SP263) assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo
6 March 2023 - The Ventana PD-L1 (SP263) assay helps determine which patients with non-small cell lung cancer may be eligible ...
Posted by Michael Wonder on 03 Mar 2023
US FDA broadens indication for Verzenio (abemaciclib) in hormone receptor positive, HER2 negative, node positive, high risk early breast cancer
3 March 2023 - Approval supported by four-year data from the monarchE trial; Verzenio added to adjuvant endocrine therapy reduced the ...
Posted by Michael Wonder on 01 Mar 2023
Nexus Pharmaceuticals receives FDA approval for Emerphed (ephedrine sulphate injection) pre-filled syringe
1 March 2023 - Nexus Pharmaceuticals announced that it has received US FDA approval for Emerphed (ephedrine sulphate injection) in 25 ...
Posted by Michael Wonder on 01 Mar 2023
Cytokinetics receives complete response letter from FDA for new drug application for omecamtiv mecarbil
28 February 2023 - Complete response letter states that GALACTIC-HF alone does not establish substantial evidence of effectiveness sufficient for approval. ...
Posted by Michael Wonder on 01 Mar 2023
Kevzara (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica
28 February 2023 - Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial. ...
Posted by Michael Wonder on 01 Mar 2023
Reata Pharmaceuticals announces FDA approval of Skyclarys (omavaloxolone), the first and only drug indicated for patients with Friedreich’s ataxia
28 February 2023 - Rare paediatric disease priority review voucher granted. ...
Posted by Michael Wonder on 24 Feb 2023
FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that offers significant bleed protection
23 February 2023 - FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that ...
Posted by Michael Wonder on 23 Feb 2023
US FDA approves Sanofi's bleeding disorder therapy
24 February 2023 - The US FDA has approved French drug maker Sanofi's therapy to treat a type of inherited ...
Posted by Michael Wonder on 19 Feb 2023
Teva announces FDA approval of Austedo XR (deutetrabenazine) extended release tablets, a new once daily formulation of Austedo (deutetrabenazine) tablets
17 February 2023 - New once daily Austedo XR regimen now approved in 6 mg, 12 mg and 24 mg tablet ...