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RSS FeedPosted by Michael Wonder on 05 Jun 2024
Adicet Bio receives FDA fast track designation for ADI-001 in lupus nephritis
5 June 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the potential ...
Posted by Michael Wonder on 05 Jun 2024
Quince Therapeutics receives US FDA fast track designation for EryDex system
3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...
Posted by Michael Wonder on 05 Jun 2024
Rinvoq (upadacitinib) now available for paediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis
4 June 2024 - First indications of Rinvoq (upadacitinib) for paediatric patients two years of age and older. ...
Posted by Michael Wonder on 04 Jun 2024
Iterum Therapeutics receives FDA acceptance of resubmission of NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections
31 May 2024 - Oral sulopenem NDA has been assigned a PDUFA action date of 25 October 2024. ...
Posted by Michael Wonder on 04 Jun 2024
Repare Therapeutics announces fast track designation granted by the FDA for lunresertib in combination with camonsertib for the treatment of platinum resistant ovarian cancer
4 June 2024 - Repare Therapeutics today announced the US FDA has granted fast track designation to lunresertib in combination with ...
Posted by Michael Wonder on 03 Jun 2024
Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation
31 May 2024 - Regeneron Pharmaceuticals and Sanofi today announced the US FDA has extended by three months the target action ...
Posted by Michael Wonder on 03 Jun 2024
Tris Pharma receives US FDA approval for once daily Onyda XR (clonidine hydrochloride) extended release oral suspension, the first and only liquid non-stimulant ADHD medication
29 May 2024 - First non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies ...
Posted by Michael Wonder on 03 Jun 2024
Teva announces Austedo XR (deutetrabenazine) extended release tablets now US FDA approved as a one pill, once daily treatment option for clinically therapeutic doses (24 mg–48 mg/day)
29 May 2024 - US FDA approves new one pill, once daily Austedo XR tablets (30 mg, 36 mg, 42 ...
Posted by Michael Wonder on 03 Jun 2024
Zanidatamab granted priority review for HER2 positive metastatic biliary tract cancer
29 May 2024 - Target action (PDUFA) date set for 29 November 2024. ...
Posted by Michael Wonder on 02 Jun 2024
US FDA acknowledges Astellas' resubmission of biologics license application for zolbetuximab and sets new action date
30 May 2024 - If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and ...
Posted by Michael Wonder on 01 Jun 2024
Cancer is capsizing Americans’ finances. ‘I was losing everything.’
28 May 2024 - Higher drug prices, rising out of pocket costs and reduced incomes create economic strain for many patients. ...
Posted by Michael Wonder on 31 May 2024
FDA plans to release AI drug development guidance this year
30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...
Posted by Michael Wonder on 31 May 2024
NH TherAguix receives FDA fast track designation for AGuIX, its novel radio-enhancer in the treatment of malignant gliomas, and provides an update on its developments and prospects
30 May 2024 - Key regulatory milestone confirming the interest of the US authorities in AGuIX, a next generation nanodrug ...
Posted by Michael Wonder on 30 May 2024
Affimed receives fast track designation for combination therapy of AFM24 with atezolizumab for EGFR wild type non-small cell lung cancer
29 May 2024 - The FDA’s fast track designation was granted after its review of the initial efficacy data of the ...
Posted by Michael Wonder on 30 May 2024
FDA use of “proxies” to expedite drug approvals not supported by evidence, analysis finds
28 May 2024 - In the world of drug development, there has been a recent movement to speed clinical trials of ...