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RSS FeedPosted by Michael Wonder on 15 Jun 2020
The pandemic claims new victims: prestigious medical journals
14 June 2020 - Two major study retractions in one month have left researchers wondering if the peer review process is ...
Posted by Michael Wonder on 13 Jun 2020
FDA approves Merck’s Gardasil 9 for the prevention of certain HPV related head and neck cancers
12 June 2020 - Gardasil (human papillomavirus 9 valent vaccine, recombinant) now approved for the prevention of HPV related cervical, ...
Posted by Michael Wonder on 13 Jun 2020
Antimicrobials benefited from expedited FDA programs more than other drugs
12 June 2020 - Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more ...
Posted by Michael Wonder on 13 Jun 2020
ZZ Biotech announces FDA fast track designation for stroke program
12 June 2020 - ZZ Biotech today announced that the US FDA has designated the investigation of the company’s experimental drug ...
Posted by Michael Wonder on 12 Jun 2020
FDA approves drug to treat infants and children with HIV
12 June 2020 - Today, the U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for ...
Posted by Michael Wonder on 12 Jun 2020
Mylan and Biocon announce U.S. FDA approval of Semglee (insulin glargine injection)
11 June 2020 - FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions ...
Posted 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. ...