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RSS FeedPosted by Michael Wonder on 12 Jul 2021
FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
9 July 2021 - The FDA’s contentious decision to approve a new Alzheimer’s drug for every single patient with the ...
Posted by Michael Wonder on 12 Jul 2021
Experts warn full FDA COVID-19 vaccine approval is no quick fix for hesitancy
12 July 2021 - The FDA issuing full approval for two COVID-19 vaccines might not be the game changer it’s ...
Posted by Michael Wonder on 10 Jul 2021
FDA seeks to probe talks between staff and Biogen on Alzheimer’s drug
9 July 2021 - The FDA’s chief is taking the highly unusual step of asking for a federal investigation of doctors ...
Posted by Michael Wonder on 10 Jul 2021
Bayer’s Kerendia (finerenone) receives U.S. FDA approval for treatment of patients with chronic kidney disease associated with type 2 diabetes
9 July 2021 - First and only non-steroidal mineralocorticoid receptor antagonist approved for adults with chronic kidney disease associated with type ...
Posted by Michael Wonder on 09 Jul 2021
FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer
10 July 2021 - On 9 July 2021, the FDA approved enfortumab vedotin-ejfv (Padcev), for adult patients with locally advanced ...
Posted by Michael Wonder on 09 Jul 2021
Pfizer plans to request FDA approval for COVID booster shot in August
9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...
Posted by Michael Wonder on 08 Jul 2021
House report: drug companies spent more on buybacks, dividends than research
8 July 2021 - House Democrats on Thursday released a report that found that the 14 leading drug companies paid ...
Posted by Michael Wonder on 08 Jul 2021
Lysogene announces FDA fast track designation for LYS-GM101 gene therapy for the treatment of GM1 gangliosidosis
8 July 2021 - Lysogene today announced that the U.S. FDA has granted fast track designation to its LYS-GM101 program, which ...
Posted by Michael Wonder on 08 Jul 2021
In a reversal, FDA calls for limits on who gets Alzheimer’s drug
8 July 2021 - The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the ...
Posted by Michael Wonder on 08 Jul 2021
FDA approves updated Aduhelm prescribing information to emphasise population studied in clinical trials
8 July 2021 - Aduhelm should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s ...
Posted by Michael Wonder on 08 Jul 2021
Tezepelumab regulatory submission accepted and granted FDA priority review in the US for the treatment of patients with asthma
8 July 2021 - Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a ...
Posted by Michael Wonder on 07 Jul 2021
Hyalex Orthopaedics receives FDA breakthrough device designation for novel Hyalex cartilage system
7 July 2021 - Hyalex Orthopaedics announced that the Hyalex Cartilage System has been granted breakthrough device designation from the U.S. ...
Posted by Michael Wonder on 07 Jul 2021
Valneva awarded FDA breakthrough designation for its single-shot Chikungunya vaccine candidate
7 July 2021 - This new U.S. milestone follows FDA fast track and EMA PRIME designations. ...
Posted by Michael Wonder on 07 Jul 2021
ChemoCentryx announces filing of amendment to NDA submission and extension of the PDUFA review period for avacopan in the treatment of ANCA associated vasculitis
6 July 2021 - ChemoCentryx today announced that, following consultations with the U.S. FDA, it filed an amendment to its new ...
Posted by Michael Wonder on 06 Jul 2021
Cures for many rare diseases might already exist. Why aren’t we using them?
5 July 2021 - Scientists may have already developed cures for cystic fibrosis, muscular dystrophy, and rare cancers—they just don't realise ...