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RSS FeedPosted by Michael Wonder on 26 Jul 2021
Full FDA approval is needed to overcome vaccine hesitancy
26 July 2021 - As the Delta variant spreads, what is the agency waiting for? ...
Posted by Michael Wonder on 26 Jul 2021
Iterum Therapeutics receives complete response letter from U.S. FDA for oral sulopenem
26 July 2021 - Iterum Therapeutics today announced that it received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 26 Jul 2021
Aadi Bioscience announces FDA acceptance and priority review for the new drug application of Fyarro for the treatment of advanced malignant PEComa
26 July 2021 - FDA grants priority review and sets PDUFA target action date of 26 November 2021 ...
Posted by Michael Wonder on 26 Jul 2021
Bristol Myers Squibb statement on Opdivo (nivolumab) monotherapy post sorafenib hepatocellular carcinoma U.S. indication
23 July 2021 - In consultation with the U.S. FDA, Bristol Myers Squibb has made the difficult decision to voluntarily withdraw ...
Posted by Michael Wonder on 25 Jul 2021
Patient advocacy organisations and FDA drug approval: lessons from Aduhelm
23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry ...
Posted by Michael Wonder on 24 Jul 2021
Incyte provides regulatory update on retifanlimab for the treatment of certain patients with squamous cell carcinoma of the anal canal
23 July 2021 - Incyte today announced that the U.S. FDA has issued a complete response letter regarding its biologics license ...
Posted by Michael Wonder on 24 Jul 2021
Dalvance (dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in paediatric patients
23 July 2021 - Dalvance is the first and only single dose infusion to treat acute bacterial skin and skin structure ...
Posted by Michael Wonder on 23 Jul 2021
Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs
22 July 2021 - In the latest look at clinical trial transparency, a new analysis found that only 26% of ...
Posted by Michael Wonder on 23 Jul 2021
‘When memory fades’: misinformation about Alzheimer’s disease and Aduhelm must be limited
21 July 2021 - Surgeon General Vivek Murthy issued a timely and thought-provoking advisory about the serious threat to public ...
Posted by Michael Wonder on 23 Jul 2021
GBT provides regulatory and pipeline updates in sickle cell disease
22 July 2021 - Submits supplemental new drug application to the U.S. FDA for Oxbryta (voxelotor) in children with SCD ages ...
Posted by Michael Wonder on 22 Jul 2021
Novartis aims to beat rivals to novel $10 billion cancer treatment market
22 July 2021 - Trial results for new targeted therapy ‘pretty remarkable’, says CEO. ...
Posted by Michael Wonder on 22 Jul 2021
FDA approves treatment for paediatric patients with type 2 diabetes mellitus
22 July 2021 - The U.S. FDA today approved Bydureon and Bydureon BCise (exenatide extended release) injection to be used in ...
Posted by Michael Wonder on 22 Jul 2021
Roche is discussing Alzheimer’s drug with FDA following regulators controversial approval of Biogen’s Aduhelm, CEO says
22 July 2021 - Roche is discussing its potential Alzheimer’s treatment with the U.S. FDA, CEO Severin Schwan said Thursday, ...
Posted by Michael Wonder on 22 Jul 2021
FDA approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination for patients with certain types of advanced endometrial carcinoma
22 July 2021 - Immunotherapy and tyrosine kinase inhibitor combination approved for the treatment of patients with advanced endometrial carcinoma that ...
Posted by Michael Wonder on 21 Jul 2021
We’re seeing what happens when the FDA loses credibility
21 July 2021 - It’s not just politicians who are worried about the decision to approve a new Alzheimer’s drug. ...