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RSS FeedPosted by Michael Wonder on 06 Aug 2020
FDA approves GSK’s Blenrep (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma
6 August 2020 - Blenrep is the fifth major medicine approval for GSK in 2020. ...
Posted by Michael Wonder on 05 Aug 2020
Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
5 August 2020 - FDA granted de novo class II for cobas EBV test following the agency’s breakthrough device designation. ...
Posted by Michael Wonder on 05 Aug 2020
Moderna is pricing coronavirus vaccine at $32 to $37 per dose for some customers
5 August 2020 - The company defines a small order of its vaccine as “in the millions.” ...
Posted by Michael Wonder on 05 Aug 2020
Johnson & Johnson reaches deal with U.S. for 100 million doses of coronavirus vaccine at more than $1 billion
5 August 2020 - The doses will be provided to Americans at no cost if they’re used in a COVID-19 vaccination ...
Posted by Michael Wonder on 05 Aug 2020
Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-12 for the treatment of narcolepsy
5 August 2020 - FDA Orphan Drug Designation previously granted to Axsome for AXS-12 in narcolepsy. ...
Posted by Michael Wonder on 05 Aug 2020
ReViral announces FDA fast track designation granted to sisunatovir for the treatment of serious respiratory syncytial virus infection
4 August 2020 - ReViral today announced that the U.S. FDA has granted fast track designation to sisunatovir for the ...
Posted by Michael Wonder on 05 Aug 2020
Leo Pharma announces US FDA fast track designation for delgocitinib cream for the treatment of adults with moderate to severe chronic hand eczema
4 August 2020 - Leo Pharma today announced that delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, has been granted fast ...
Posted by Michael Wonder on 05 Aug 2020
Cerecor receives rare paediatric disease designation for CERC-006 in lymphatic malformations
4 August 2020 - Cerecor today announced that the U.S. FDA granted rare paediatric disease designation to CERC-006, a dual inhibitor ...
Posted 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 ...