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RSS FeedPosted by Michael Wonder on 21 Dec 2021
Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA
20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...
Posted by Michael Wonder on 20 Dec 2021
EMA recommends Nuvaxovid for authorisation in the EU
20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...
Posted by Michael Wonder on 20 Dec 2021
EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency
17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...
Posted by Michael Wonder on 20 Dec 2021
Edenbridge Pharmaceuticals announces U.S. FDA approval of Dartisla ODT (glycopyrrolate) orally disintegrating tablets
17 December 2021 - First and only orally disintegrating tablet of glycopyrrolate. ...
Posted by Michael Wonder on 20 Dec 2021
Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus
20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...
Posted by Michael Wonder on 20 Dec 2021
CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults
17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...
Posted by Michael Wonder on 19 Dec 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for the treatment of paediatric patients with iron deficiency anaemia
15 December 2021 - For patients as young as one year of age who have intolerance to, or have had ...
Posted by Michael Wonder on 19 Dec 2021
FDA approves Telix’s prostate cancer imaging product, Illuccix
19 December 2021 - Telix Pharmaceuticals today announces that the United States FDA has approved Telix’s lead prostate cancer imaging product, ...
Posted by Michael Wonder on 19 Dec 2021
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) as first-line treatment for ALK positive advanced lung cancer
17 December 2021 - Recommendation based on results from the Phase 3 CROWN trial, which showed Lorviqua reduced the risk of ...
Posted by Michael Wonder on 19 Dec 2021
Xalud Therapeutics receives FDA fast track designation for XT-150 for the treatment of pain associated with osteoarthritis of the knee
17 December 2021 - Xalud Therapeutics announced today that the United States FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 19 Dec 2021
Fist Assist Devices receives FDA “breakthrough device” designation for the world’s first wearable vein dilation device for ESRD patients
16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...
Posted by Michael Wonder on 19 Dec 2021
ATAGI update following weekly COVID-19 meeting (15 December 2021)
18 December 2021 - On Wednesday 15 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety. ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 18 Dec 2021
bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor
17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...
Posted by Michael Wonder on 18 Dec 2021
FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
17 December 2021 - The FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in paediatric ...