Blog
RSS FeedPosted by Michael Wonder on 17 May 2023
Ozempic is hard to find. Some pharmacies are offering unauthorised alternatives.
16 May 2023 - Regulators are raising concerns about compounded semaglutide. ...
Posted by Michael Wonder on 17 May 2023
Lumen Bioscience receives fast track designation from US FDA for LMN-201
17 May 2023 - Orally delivered biologic drug for treatment and prevention of C. difficile infection. ...
Posted by Michael Wonder on 17 May 2023
US FDA grants priority review of TAK-755 for the treatment of congenital thrombotic thrombocytopenic purpura
16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation ...
Posted by Michael Wonder on 17 May 2023
Bayer receives US FDA fast track designation for asundexian atrial fibrillation program
16 May 2023 - The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program ...
Posted by Michael Wonder on 16 May 2023
U.S. Food and Drug Administration issues complete response letter for Byondis' trastuzumab duocarmazine
15 May 2023 - Complete response letter outlines FDA's request for additional information. ...
Posted by Michael Wonder on 16 May 2023
The decline of science at the FDA has become unmanageable
15 May 2023 - Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings ...
Posted by Michael Wonder on 16 May 2023
Innovent receives NMPA breakthrough designation for IBI351 (KRASG12C inhibitor) as monotherapy for previously treated advanced colorectal carcinoma
15 May 2023 - Innovent Biologics announced that the Center for Drug Evaluation of China’s National Medical Products Administration has granted ...
Posted by Michael Wonder on 15 May 2023
Caldolor now FDA approved for treatment of fever & pain in infants
15 May 2023 - Caldolor is the only injectable non-opioid approved for treating pain in infants. ...
Posted by Michael Wonder on 15 May 2023
Drug companies are minting billions on unproven treatments with FDA shortcut
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
Posted by Michael Wonder on 12 May 2023
FDA approves novel drug to treat moderate to severe hot flashes caused by menopause
12 May 2023 - Today, the US FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe ...
Posted by Michael Wonder on 11 May 2023
FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis
9 May 2023 - The objective of this study was to analyse the US FDA approval, trials, unmet needs, benefit, and ...
Posted by Michael Wonder on 11 May 2023
Otsuka and Lundbeck announce US FDA approval of supplemental new drug application for Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease
10 May 2023 - Rexulti is the first and only pharmacological treatment approved in the US for agitation associated with ...
Posted by Michael Wonder on 11 May 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce FDA approval of Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease
10 May 2023 - PEGylated enzyme replacement therapy designed to provide long half-life. ...
Posted by Michael Wonder on 10 May 2023
Acrivon Therapeutics announces FDA grants fast track designation for development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer
9 May 2023 - In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy ...
Posted by Michael Wonder on 09 May 2023
FDA accepts application for Genentech’s Vabysmo for the treatment of retinal vein occlusion
9 May 2023 - Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting ...