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RSS FeedPosted by Michael Wonder on 04 Aug 2020
Biosight granted U.S. FDA fast track designation for BST-236 for the treatment of acute myeloid leukaemia
4 August 2020 - Biosight today announced that that the U.S. FDA has granted fast track designation for BST-236 (aspacytarabine) ...
Posted by Michael Wonder on 04 Aug 2020
Pacira BioSciences announces FDA acceptance of sNDA for Exparel use in paediatric patients
4 August 2020 - sNDA submission based on positive Phase 3 data supporting expansion of the Exparel label to include use ...
Posted by Michael Wonder on 04 Aug 2020
Goldman Sachs predicts FDA will approve coronavirus vaccine this year
3 August 2020 - Goldman Sachs expects the Food and Drug Administration to approve at least one coronavirus vaccine this ...
Posted by Michael Wonder on 04 Aug 2020
DBV Technologies receives complete response letter from FDA for Viaskin Peanut BLA in children ages 4-11 years
4 August 2020 - DBV Technologies today announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 03 Aug 2020
Janssen announces U.S. FDA approval of Spravato (esketamine) nasal spray to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behaviour
3 August 2020 - Approval is based on Phase 3 data showing Spravato reduced depressive symptoms in as little as four ...
Posted by Michael Wonder on 03 Aug 2020
FDA accepts and grants priority review of Vanda's applications for Hetlioz (tasimelteon) in the treatment of Smith-Magenis syndrome
3 August 2020 - Vanda Pharmaceuticals today announced that the U.S. FDA has accepted for priority review Vanda's applications for Smith-Magenis ...
Posted by Michael Wonder on 03 Aug 2020
PolyPid granted fast track designation from FDA for D-PLEX for prevention of surgical site infections in abdominal surgery
3 August 2020 - PolyPid today announced that D-PLEX100 has received fast track designation from the U.S. FDA for the prevention ...
Posted by Michael Wonder on 03 Aug 2020
FDA grants fast track designation for BCX9930 in PNH
3 August 2020 - BioCryst Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for its oral ...
Posted by Michael Wonder on 03 Aug 2020
Sonoran Biosciences announces qualified infectious disease product designation granted by FDA for SBG003 for surgical site infections in abdominal surgery
3 August 2020 - QIDP designation allows for FDA priority review, fast-track designation and an additional five years of market exclusivity ...
Posted by Michael Wonder on 03 Aug 2020
Imara announces IMR-687 granted fast track designation and rare paediatric disease designation for treatment of beta-thalassaemia
30 July 2020 - Imara today announced the U.S. FDA has granted fast track designation and rare paediatric disease designation for ...
Posted by Michael Wonder on 03 Aug 2020
Characteristics and strength of evidence of COVID-19 studies registered on ClinicalTrials.gov
27 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has led to a massive activation of clinical research. ...
Posted by Michael Wonder on 01 Aug 2020
FDA approves new indication for drug containing an active ingredient derived from cannabis to treat seizures in rare genetic disease
31 July 2020 - Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) oral solution for the treatment of seizures ...
Posted by Michael Wonder on 01 Aug 2020
FDA approves Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
31 July 2020 - First FDA approval of a second-line treatment for adult patients with relapsed or refractory diffuse large B-cell ...
Posted by Michael Wonder on 31 Jul 2020
Medicare expands coverage for BRACAnalysis CDx in prostate cancer
31 July 2020 - Myriad Genetics announced today that Medicare has expanded coverage for BRACAnalysis CDx for men with prostate cancer ...
Posted by Michael Wonder on 31 Jul 2020
Weighing the benefits and risks of proliferating observational treatment assessments: observational cacophony, randomised harmony
31 July 2020 - Amid the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, substantial effort is being directed toward ...