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RSS FeedPosted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 09 Sep 2021
Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations
9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...
Posted by Michael Wonder on 09 Sep 2021
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...
Posted by Michael Wonder on 09 Sep 2021
FDA grants Jardiance breakthrough therapy designation for heart failure with preserved ejection fraction
9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...
Posted by Michael Wonder on 09 Sep 2021
COVID-19 vaccine weekly safety report (9 September 2021)
9 September 2021 - To 5 September 2021, approximately 21 million vaccine doses have been given in Australia – 13.1 million ...
Posted by Michael Wonder on 09 Sep 2021
Albireo sells priority review voucher for $105 million
7 September 2021 - PRV was granted to Albireo with the FDA approval of Bylvay (odevixibat) in July. ...
Posted by Michael Wonder on 08 Sep 2021
Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita (burosumab injection) for the treatment of tumour induced osteomalacia in adults
7 September 2021 - Ultragenyx Pharmaceutical today announced that Crysvita (burosumab Injection) has been approved by Health Canada for the treatment ...
Posted by Michael Wonder on 08 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device
8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...
Posted by Michael Wonder on 08 Sep 2021
Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection
8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...
Posted by Michael Wonder on 08 Sep 2021
FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
Posted by Michael Wonder on 08 Sep 2021
HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU
8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...
Posted by Michael Wonder on 07 Sep 2021
TGA approves new cancer medicine
7 September 2021 - Luspatercept (Reblozyl) is used to treat patients with certain transfusion-dependent anaemias. ...