Blog
RSS FeedPosted by Michael Wonder on 29 Mar 2022
Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy
29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...
Posted by Michael Wonder on 29 Mar 2022
Consequences of US FDA approval decisions in high-income countries
29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence ...
Posted by Michael Wonder on 28 Mar 2022
U.S. FDA approves Fintempla (fenfluramine) oral solution for treatment of seizures associated with Lennox-Gastaut syndrome
28 March 2022 - Approval based on data where fenfluramine demonstrated efficacy in the most difficult to treat seizure types, including ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...
Posted by Michael Wonder on 24 Mar 2022
Pressured by patients, FDA reviews ALS drug with modest data
25 March 2022 - The FDA meets next week to review a closely watched drug for ALS, or Lou Gehrig’s ...
Posted by Michael Wonder on 24 Mar 2022
Fresenius Kabi announces FDA approval of SMOFlipid lipid injectable emulsion for paediatric patients requiring parenteral nutrition
24 March 2022 - First and only four-oil lipid injectable emulsion indicated for paediatric parenteral nutrition, including term and preterm neonates. ...
Posted by Michael Wonder on 24 Mar 2022
U.S. FDA approves streamlined process for initiating HIV therapy with Cabenuva (cabotegravir and rilpivirine), the first and only complete long-acting injectable HIV treatment
24 March 2022 - Adults living with HIV now have an option to start injectable regimen without the need for ...
Posted by Michael Wonder on 24 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults
24 March 2022 - Pfizer today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy ...
Posted by Michael Wonder on 24 Mar 2022
Fennec Pharmaceuticals resubmits new drug application to the U.S. FDA for Pedmark
24 March 2022 - Fennec Pharmaceuticals today announced the resubmission of its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 24 Mar 2022
Lilly announces complete response letter for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer
24 March 2022 - Eli Lilly today announced that the U.S. FDA has issued a complete response letter (CRL) for ...
Posted by Michael Wonder on 23 Mar 2022
Novartis Pluvicto approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer
23 March 2022 - FDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA ...
Posted by Michael Wonder on 23 Mar 2022
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age
23 March 2022 - Moderna today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 ...
Posted by Michael Wonder on 23 Mar 2022
StemCyte has submitted its application for a biologics license for its allogeneic umbilical cord haematopoietic progenitor cell product "HPC-Cord Blood", to the US FDA
22 March 2022 - The BLA has been accepted for quality review and StemCyte anticipates licensure in 2023 ...
Posted by Michael Wonder on 23 Mar 2022
Instrumental variables and heterogeneous treatment effects
22 March 2022 - A randomised clinical trial can be used to estimate the average treatment effect for a population. ...
Posted by Michael Wonder on 22 Mar 2022
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted rare paediatric disease designation by the US FDA for the treatment of neuroblastoma
21 March 2022 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a rare paediatric disease ...