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RSS FeedPosted by Michael Wonder on 10 Aug 2021
Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
Posted by Michael Wonder on 10 Aug 2021
After court defeat, FDA shifts to regulating some drugs as devices
9 August 2021 - The US FDA is informing stakeholders and the public that it will soon begin implementing a ...
Posted by Michael Wonder on 10 Aug 2021
Acer Therapeutics and Relief Therapeutics announce submission of a new drug application to the U.S. FDA for ACER-001 for treatment of urea cycle disorders
9 August 2021 - Acer Therapeutics and Relief Therapeutics today announced the submission of a new drug application to the U.S. ...
Posted by Michael Wonder on 10 Aug 2021
Liminal BioSciences announces sale of priority review voucher for USD105 million
9 August 2021 - Liminal BioSciences announced today that its subsidiary ProMetic Biotherapeutics has entered into a definitive agreement to ...
Posted by Michael Wonder on 09 Aug 2021
Ophthalmologist group wants U.S. Government to push back against Avastin biosimilars
10 August 2021 - The American Academy of Ophthalmology says biosimilar alternatives to Avastin have never been tested in the ...
Posted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...
Posted by Michael Wonder on 09 Aug 2021
Skyrizi (risankizumab-rzaa) now available in the U.S. as a single 150 mg injection for adults with moderate to severe plaque psoriasis
9 August 2021 - Skyrizi is now the only four-dose-a-year biologic for psoriasis with options to administer via a single-dose pen ...
Posted by Michael Wonder on 09 Aug 2021
Calliditas receives FDA fast track designation for setanaxib in PBC
9 August 2021 - Calliditas Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead NOX ...
Posted by Michael Wonder on 08 Aug 2021
Biden yet to nominate new FDA chief even as delta surges
8 August 2021 - President Biden has yet to nominate a permanent head of the FDA at a time when ...
Posted by Michael Wonder on 08 Aug 2021
US tropical disease priority review vouchers: lessons in promoting drug development and access
6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...
Posted by Michael Wonder on 06 Aug 2021
Actuate Therapeutics announces FDA fast track designation for 9-ING-41 for treatment of pancreatic cancer
5 August 2021 - Actuate Therapeutics today announced that the U.S. FDA has granted fast track designation for 9-ING-41 for treatment ...
Posted by Michael Wonder on 06 Aug 2021
FDA approves new treatment for Pompe disease
6 August 2021 - Today, the U.S. FDA approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of ...
Posted by Michael Wonder on 06 Aug 2021
Spectrum Pharmaceuticals receives complete response letter from FDA for Rolontis (eflapegrastim)
6 August 2021 - Spectrum Pharmaceuticals today announced receipt of a complete response letter from the U.S. FDA regarding the company’s ...
Posted by Michael Wonder on 06 Aug 2021
Merck’s Keytruda (pembrolizumab) significantly prolonged recurrence-free survival compared to placebo as adjuvant therapy for patients with stage II resected high-risk melanoma in Phase 3 KEYNOTE-716 trial
5 August 2021 - US FDA grants priority review to Merck’s application for Keytruda based on these data. ...
Posted by Michael Wonder on 06 Aug 2021
Novavax delays Covid vaccine emergency authorisation submission to FDA until fourth quarter
5 August 2021 - The company says it is still on track to produce 100 million doses per month by the ...