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RSS FeedPosted by Michael Wonder on 07 Jul 2021
ChemoCentryx announces filing of amendment to NDA submission and extension of the PDUFA review period for avacopan in the treatment of ANCA associated vasculitis
6 July 2021 - ChemoCentryx today announced that, following consultations with the U.S. FDA, it filed an amendment to its new ...
Posted by Michael Wonder on 06 Jul 2021
Cures for many rare diseases might already exist. Why aren’t we using them?
5 July 2021 - Scientists may have already developed cures for cystic fibrosis, muscular dystrophy, and rare cancers—they just don't realise ...
Posted by Michael Wonder on 06 Jul 2021
Knight Therapeutics announces Health Canada approval for Nerlynx (neratinib) to treat HER2 positive metastatic breast cancer
6 July 2021 - Knight Therapeutics announced today that Health Canada has approved Nerlynx (neratinib) in combination with capecitabine for the ...
Posted by Michael Wonder on 06 Jul 2021
Novartis tries to rescue stalled inclisiran filing with FDA
6 July 2021 - Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US ...
Posted by Michael Wonder on 06 Jul 2021
FDA grants priority review for Levo Therapeutics’ new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome
6 July 2021 - Levo Therapeutics announced today that the U.S. FDA has granted priority review for its new drug application ...
Posted by Michael Wonder on 06 Jul 2021
ANI Pharmaceuticals announces refiling of Cortrophin sNDA with FDA
6 July 2021 - ANI Pharmaceuticals today announced that the Company has re-filed its supplemental new drug application for Cortrophin Gel ...
Posted by Michael Wonder on 06 Jul 2021
Provention Bio receives complete response letter to biologics license application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
6 July 2021 - Previously reported pharmacokinetic drug product comparability considerations remain outstanding. ...
Posted by Michael Wonder on 06 Jul 2021
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in locally advanced cutaneous squamous cell carcinoma
6 July 2021 - Keytruda is now approved for the treatment of patients with recurrent or metastatic or locally advanced ...
Posted by Michael Wonder on 06 Jul 2021
Athenex provides update from FDA Type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the ...
Posted by Michael Wonder on 06 Jul 2021
Opthea’s OPT-302 granted FDA fast track designation for wet age-related macular degeneration
6 July 2021 - FDA’s Fast Track Designation for OPT-302 offers benefits to expedite the OPT-302 Phase 3 clinical program and ...
Posted by Michael Wonder on 06 Jul 2021
The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease
6 July 2021 - A new treatment targets amyloid clumps in the brain, but researchers have long debated whether that will ...
Posted by Michael Wonder on 05 Jul 2021
It’s time for the FDA to fully approve the mRNA vaccines
1 July 2021 - Here’s a paradox: a new drug for Alzheimer’s disease, aducanumab, gets approved by the FDA through an ...
Posted 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. ...