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RSS FeedPosted by Michael Wonder on 12 Jul 2023
BeiGene announces FDA acceptance of sNDA for fifth Brukinsa indication
12 July 2023 - Submission seeks approval for Brukinsa in combination with obinutuzumab as a treatment for relapsed or refractory follicular ...
Posted by Michael Wonder on 12 Jul 2023
Renibus Therapeutics announces breakthrough therapy designation from US FDA for RBT-1 for the reduction in risk of post-operative complications in patients undergoing cardiothoracic surgery
11 July 2023 - RBT-1 is a first in class, pre-conditioning drug in the cardiothoracic surgery setting. ...
Posted by Michael Wonder on 11 Jul 2023
Xspray Pharma receives request for additional information concerning Dasynoc from FDA
11 July 2023 - Xspray Pharma announces an update on recent developments regarding the company’s first product, Dasynoc, currently under review ...
Posted by Michael Wonder on 11 Jul 2023
Express Scripts adds three biosimilars to largest formulary to promote competition and advance affordability, choices for patients
11 July 2023 - Express Scripts will include Cyltezo and both Sandoz products (Hyrimoz and unbranded adalimumab-adaz) – inflammatory disease biosimilars ...
Posted by Michael Wonder on 11 Jul 2023
FDA to import more Chinese cancer drugs amid shortage
10 July 2023 - The FDA is opening the way for more cancer drugs from China as the US continues ...
Posted by Michael Wonder on 10 Jul 2023
Idacio (adalimumab-aacf) now available in the United States
3 July 2023 - CMS grants Fresenius Kabi permanent, product-specific Q Code for Idacio (adalimumab-aacf). ...
Posted by Michael Wonder on 10 Jul 2023
Association of Advisory Committee votes with US FDA - a decision-making on prescription drugs (2010-2021)
11 July 2023 - In this qualitative study of 409 advisory committee meetings, overall, 88% of FDA regulatory actions aligned ...
Posted by Michael Wonder on 10 Jul 2023
US FDA approves expanded indication for Novartis Leqvio (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease
10 July 2023 - Expanded indication now enables broader use of Leqvio for LDL-C reduction in patients with primary hyperlipidaemia (high ...
Posted by Michael Wonder on 09 Jul 2023
After five years of successful experience internationally, Biocon Biologics’ Hulio biosimilar to Humira, now available in the United States
3 July 2023 - Biocon Biologics today announced that Hulio (adalimumab-fkjp) injection, a biosimilar to Humira (adalimumab), is now available ...
Posted by Michael Wonder on 06 Jul 2023
FDA converts novel Alzheimer’s disease treatment to traditional approval
6 July 2023 - Action follows confirmatory trial to verify clinical benefit. ...
Posted by Michael Wonder on 06 Jul 2023
Kazia's paxalisib receives fast track designation from FDA for treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy
6 July 2023 - Kazia Therapeutics is pleased to announce that its lead program, paxalisib, has been awarded fast track ...
Posted by Michael Wonder on 06 Jul 2023
Astellas announces US FDA grants priority review for zolbetuximab biologics license application
6 July 2023 - Astellas Pharma today announced that the US FDA has accepted and granted priority review for the company’s ...
Posted by Michael Wonder on 04 Jul 2023
Amneal launches authorised generic for Xyrem (sodium oxybate) and receives FDA approval for five complex generics in the second quarter
3 July 2023 - Launches authorized generic for Xyrem (sodium oxybate) in the US, representing another new complex generic product launch. ...
Posted by Michael Wonder on 03 Jul 2023
Nevakar Injectables announces FDA approval of cyclophosphamide RTD solution
3 July 2023 - Ready to dilute, multi-dose vials reduce compounding time and waste. ...
Posted by Michael Wonder on 03 Jul 2023
Amneal receives US FDA complete response letter for IPX203
3 July 2023 - Letter requests additional pharmacokinetic data. ...