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RSS FeedPosted by Michael Wonder on 05 Jul 2021
Merck provides update on Keytruda (pembrolizumab) indication in third-line gastric cancer in the US
1 July 2021 - Merck today announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda ...
Posted by Michael Wonder on 05 Jul 2021
Statement for health care professionals: how COVID-19 vaccines are regulated for safety and effectiveness
5 July 2021 - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization. ...
Posted by Michael Wonder on 05 Jul 2021
Medical devices reforms: enhancements to post-market monitoring
5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
Posted by Michael Wonder on 04 Jul 2021
Sonic Healthcare USA to offer assay to aid in the selection of Jemperli (dostarlimab-gxly) therapy in endometrial cancer
2 July 2021 - LMC Pathology Services, a Sonic Healthcare USA Anatomic Pathology Practice, is the first reference laboratory in ...
Posted by Michael Wonder on 04 Jul 2021
Galderma receives FDA approval for Restylane Contour for cheek augmentation and correction of midface contour deficiencies
29 June 2021 - Galderma's first and only product in the U.S. to use proprietary XpresHAn Technology for the cheeks. ...
Posted by Michael Wonder on 03 Jul 2021
Iterum Therapeutics provides regulatory update
1 July 2021 - Iterum Therapeutics today announced that the Company received a letter from the U.S.FDA stating that, as ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 01 Jul 2021
Lupin announces FDA approval of supplemental new drug application for Solosec (secnidazole) for the treatment of trichomoniasis
1 July 2021 - Solosec demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on ...
Posted by Michael Wonder on 01 Jul 2021
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
30 June 2021 - Former health secretary Donna Shalala called for a federal investigation into the FDA’s polarising approval of ...
Posted by Michael Wonder on 01 Jul 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for Alunbrig (brigatinib) to identify patients with ALK positive metastatic non-small cell lung cancer
1 July 2021 - Foundation Medicine today announced that it has received approval from the U.S. FDA for FoundationOne CDx to ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves supplemental new drug application for Adhansia XR (methylphenidate hydrochloride) extended release capsules
1 June 2021 - Phase 3 adult laboratory classroom study confirmed that Adhansia XR provided rapid and sustained symptom relief ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves dose escalation label update for Puma Biotechnology’s Nerlynx (neratinib) in HER2 positive early stage and metastatic breast cancer
1 June 2021 - Dose escalation of Nerlynx therapy demonstrated improved management and prevention of Grade 3 diarrhoea. ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves component of treatment regimen for most common childhood cancer
30 June 2021 - Today, the U.S. FDA approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen ...
Posted by Michael Wonder on 01 Jul 2021
LEXEO Therapeutics receives rare paediatric disease designation and orphan drug designation for LX2006 for the treatment of Friedreich’s ataxia
30 June 2021 - Phase I/II clinical trial in patients with cardiomyopathy associated with Friedreich’s ataxia expected to initiate in 2021. ...
Posted by Michael Wonder on 01 Jul 2021
Neuroelectrics granted FDA breakthrough device designation for new therapeutic neuromodulation platform to treat refractory focal epilepsy
30 June 2021 - In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44% median ...