Blog
RSS FeedPosted by Michael Wonder on 11 Jun 2020
Cell and gene therapies: FDA official on COVID-19 impact
10 June 2020 - Speaking at a session on cell and gene therapies at BIO Digital on Monday, a top US ...
Posted by Michael Wonder on 11 Jun 2020
U.S. FDA Commissioner says agency seeks fast review of COVID-19 products
11 June 2020 - The U.S. FDA is seeking to review treatments and tests for COVID-19 “as fast as we can” ...
Posted by Michael Wonder on 11 Jun 2020
FDA approves Pfizer's oncology supportive care biosimilar Nyvepria (pegfilgrastim-apgf)
11 June 2020 - Pfizer today announced the United States FDA has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). ...
Posted by Michael Wonder on 11 Jun 2020
FDA approves new therapy for rare disease affecting optic nerve, spinal cord
11 June 2020 - Second FDA approved therapy for neuromyelitis optica spectrum disorder offers patients additional treatment option. ...
Posted by Michael Wonder on 11 Jun 2020
Rare disease therapy development and access remain top FDA priorities during COVID-19
11 June 2020 - The FDA’s work on behalf of people with rare diseases is more important than ever as these ...
Posted by Michael Wonder on 11 Jun 2020
Rezolute receives rare paediatric disease designation for RZ358, Phase 2b candidate for the treatment of congenital hyperinsulinism, enabling eligibility for priority review voucher
10 June 2020 - Rezolute today announced that the company has received rare paediatric disease designation from the FDA for ...
Posted by Michael Wonder on 11 Jun 2020
U.S. Food and Drug Administration approves Opdivo (nivolumab) for the treatment of patients with advanced oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy
10 June 2020 - Opdivo demonstrated superior overall survival benefit compared to docetaxel or paclitaxel. ...
Posted by Michael Wonder on 11 Jun 2020
US FDA approves updated Novartis Beovu label to include additional safety information
11 June 2020 - Novartis worked with US FDA to update Beovu (brolucizumab) prescribing information to guide healthcare professionals in their ...
Posted by Michael Wonder on 10 Jun 2020
F2G’s olorofim receives both FDA orphan drug designation for Coccidioidomycosis (Valley fever) and FDA QIDP designation for multiple fungal infections
10 June 2020 - Olorofim is currently in Phase 2b development for the treatment of life-threatening fungal infections. ...
Posted by Michael Wonder on 10 Jun 2020
Price limits will scare off COVID-19 vaccine makers, Fauci warns
10 June 2020 - More than one vaccine will be needed, Fauci says. ...
Posted by Michael Wonder on 10 Jun 2020
Cardiff Oncology announces expanded access program for onvansertib in KRAS mutated metastatic colorectal cancer as follow-on to fast track designation
9 June 2020 - Expanded Access Program provides pathway for patients to gain access to treatment with onvansertib outside of clinical ...
Posted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal ...
Posted by Michael Wonder on 09 Jun 2020
The US government's supply of the only proven COVID-19 drug runs out at the end of the month
8 June 2020 - The US government's current supply of remdesivir, the only drug known to work against COVID-19, will ...
Posted by Michael Wonder on 09 Jun 2020
BioCryst announces berotralstat expanded access program for patients with hereditary angioedema in United States
9 June 2020 - BioCryst Pharmaceuticals today announced that the company has established an expanded access program with oral, once-daily ...
Posted by Michael Wonder on 09 Jun 2020
The coronavirus pandemic is reigniting a fierce debate over compounded drugs
9 June 2020 - In hopes of alleviating potential drug shortages and other issues wrought by the coronavirus pandemic, the ...