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RSS FeedPosted by Michael Wonder on 03 Jun 2024
Bavarian Nordic submits supplemental BLA seeking US FDA approval of freeze dried formulation of smallpox and mpox vaccine
31 May 2024 - Bavarian Nordic today announced the submission of a supplemental biologics license application to the US FDA ...
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
Moderna receives US FDA approval for RSV vaccine mRESVIA
31 May 2024 - mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes ...
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30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...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
ICER publishes evidence report on treatment for chronic obstructive pulmonary disease
30 May 2024 - Ensifentrine has a novel mechanism of action for an inhaled therapy; treatment would achieve common thresholds ...
Posted by Michael Wonder on 30 May 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as a new CAR T-cell therapy for relapsed or refractory mantle cell lymphoma
30 May 2024 - In the MCL cohort of TRANSCEND-NHL-001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion ...
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 ...
Posted by Michael Wonder on 30 May 2024
FDA grants priority review to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
29 May 2024 - The target action date for the FDA decision is 27 November 2024. ...