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RSS FeedPosted by Michael Wonder on 24 Nov 2021
Swiss regulator approves Pfizer/BioNTech booster for 16 and up
23 November 2021 - Swissmedic has approved the extension of COVID-19 boosters for the Pfizer/BioNTech vaccine to all people aged 16 ...
Posted by Michael Wonder on 24 Nov 2021
Health Canada approves Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
23 November 2021 - Conditional approval based on data from Phase 3 KEYNOTE-355 trial; introduces first breast cancer indication for ...
Posted by Michael Wonder on 24 Nov 2021
HAGAR GWave awarded FDA breakthrough device designation
23 November 2021 - Expediting development of GWave technology that may potentially improve the health and quality of life for millions ...
Posted by Michael Wonder on 24 Nov 2021
FDA approves first treatment for common type of post-transplant infection that is resistant to other drugs
23 November 2021 - Today, the U.S. FDA approved Livtencity (maribavir) as the first drug for treating adults and paediatric patients ...
Posted by Michael Wonder on 23 Nov 2021
The BBB’s threat to biosimilar drug development
23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...
Posted by Michael Wonder on 23 Nov 2021
Use of confidence intervals in interpreting non-statistically significant results
23 November 2021 - The goal of much of medical research is to determine which of 2 or more therapeutic approaches ...
Posted by Michael Wonder on 23 Nov 2021
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
23 November 2021 - EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). ...
Posted by Michael Wonder on 23 Nov 2021
Amryt provides update on regulatory review process for Oleogel-S10
23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022. ...
Posted by Michael Wonder on 23 Nov 2021
Seqirus announces U.S. FDA approval for multi-dose vial presentation of first ever adjuvanted, cell based pandemic influenza vaccine
23 November 2021 - The FDA has granted approval of multi-dose vial presentation for Audenz to help protect individuals six months ...
Posted by Michael Wonder on 23 Nov 2021
Isofol Medical receives FDA fast track designation for arfolitixorin in advanced colorectal cancer
23 November 2021 - Isofol Medical announced today that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 23 Nov 2021
Prilenia receives fast track designation for pridopidine for the treatment of Huntington’s disease
17 November 2021 - Prilenia Therapeutics today announced that the U.S. FDA has granted Fast Track designation to pridopidine for ...
Posted by Michael Wonder on 23 Nov 2021
Update on regulatory review of aducanumab in the European Union
17 November 2021 - Biogen and Eisai announced today an update on the on-going review of the marketing authorisation application ...
Posted by Michael Wonder on 23 Nov 2021
Aadi Bioscience announces FDA approval of its first product Fyarro for patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumour
23 November 2021 - Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ...
Posted by Michael Wonder on 22 Nov 2021
Deciphera receives European Commission approval of Qinlock for the treatment of fourth-line gastro-intestinal stromal tumour
22 November 2021 - Qinlock significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall ...
Posted by Michael Wonder on 22 Nov 2021
European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
19 November 2021 - Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people ...