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RSS FeedPosted by Michael Wonder on 31 May 2024
Highlights from the 27-30 May 2024 CHMP meeting
31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...
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30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...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 31 May 2024
Annual report highlights progress in science, medicines and health in 2023
30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...
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
European Commission adopts rules for joint clinical assessments
29 May 2024 - The European Commission has adopted joint clinical assessment rules detailing how national health care systems should ...
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
Vyluma announces marketing authorisation application validation for the European Union
29 May 2024 - Vyluma announced today that the EMA has validated the marketing authorisation application for its lead compound, NVK002. ...
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. ...
Posted by Michael Wonder on 29 May 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
29 May 2024 - Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant ...
Posted by Michael Wonder on 29 May 2024
FDA grants accelerated approval to selpercatinib for paediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumours
29 May 2024 - Today, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for certain paediatric patients two ...
Posted by Michael Wonder on 29 May 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an ...
Posted by Michael Wonder on 29 May 2024
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to ...
Posted by Michael Wonder on 28 May 2024
Vera Therapeutics receives US FDA breakthrough therapy designation for atacicept in immunoglobulin A nephropathy
28 May 2024 - Vera Therapeutics today announced that the US FDA has granted breakthrough therapy designation to atacicept for the ...