Blog
RSS FeedPosted by Michael Wonder on 25 Aug 2021
Stealth BioTherapeutics submits elamipretide new drug application to FDA for treatment of Barth syndrome
24 August 2021 - Stealth BioTherapeutics today announced the submission of a new drug application to the U.S. FDA for elamipretide, ...
Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
Posted by Michael Wonder on 24 Aug 2021
Humanetics Corporation’s BIO 300 receives fast track designation from FDA
24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...
Posted by Michael Wonder on 24 Aug 2021
FDA approves expanded peripheral artery disease indication for Xarelto (rivaroxaban) plus aspirin to include patients after lower extremity revascularisation due to symptomatic peripheral artery disease
24 August 2021 - Xarelto is the first and only therapy indicated for both coronary artery disease and peripheral artery disease, ...
Posted by Michael Wonder on 24 Aug 2021
FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update
23 August 2021 - The FDA and the drug industry have jointly agreed to create several new pilot programs aimed ...
Posted by Michael Wonder on 24 Aug 2021
FDA grants breakthrough device designation for renal failure
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
Posted by Michael Wonder on 23 Aug 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full U.S. FDA approval for individuals 16 years and older
23 August 2021 - Comirnaty is the first COVID-19 vaccine to be granted FDA approval. ...
Posted by Michael Wonder on 23 Aug 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of Korsuva (difelikefalin) injection for the treatment of moderate to severe pruritus in hemodialysis patients
23 August 2021 - Promotional launch of Korsuva injection in the U.S. is expected in Q1 2022, with reimbursement in H1 ...
Posted by Michael Wonder on 23 Aug 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Orencia (abatacept) for the prevention of acute graft versus host disease
23 August 2021 - The sBLA is supported by the Phase 2 ABA2 trial evaluating Orencia in adults and children to ...
Posted by Michael Wonder on 23 Aug 2021
Estimands, estimators and estimates
23 August 2021 - The primary goal of most randomised clinical trials is to draw conclusions about the effect of a ...
Posted by Michael Wonder on 23 Aug 2021
FDA approves first COVID-19 vaccine
23 August 2021 - Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. ...
Posted by Michael Wonder on 23 Aug 2021
Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...
Posted by Michael Wonder on 22 Aug 2021
Accelerated approval - an unexpected pathway to value-based pricing?
18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...
Posted by Michael Wonder on 21 Aug 2021
Competition, consolidation and evolution in the pharmacy market
12 August 2021 - Implications for efforts to contain drug prices and spending. ...
Posted by Michael Wonder on 20 Aug 2021
FDA approves nivolumab for adjuvant treatment of urothelial carcinoma
20 August 2021 - On 19 August 2021, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of ...