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RSS FeedPosted by Michael Wonder on 20 May 2021
FDA approves nivolumab for resected oesophageal or GEJ cancer
20 May 2021 - Today the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for patients with completely resected oesophageal or gastro-oesophageal ...
Posted by Michael Wonder on 20 May 2021
FDA authorises longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution, making vaccine more widely available
19 May 2021 - Based on a review of recent data submitted by Pfizer today, the U.S. FDA is authorising undiluted, ...
Posted by Michael Wonder on 19 May 2021
Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...
Posted by Michael Wonder on 19 May 2021
BioXcel Therapeutics announces FDA acceptance for filing of NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
19 May 2021 - FDA sets PDUFA action date for 5 January 2022. ...
Posted by Michael Wonder on 19 May 2021
BeiGene announces U.S. FDA acceptance and priority review of supplemental new drug application for Brukinsa (zanubrutinib) in marginal zone lymphoma
19 May 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa ...
Posted by Michael Wonder on 19 May 2021
FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data
18 May 2021 - Today, the U.S. FDA's Oncology Center of Excellence launched the “Send Your Oncology Research Questions to ...
Posted by Michael Wonder on 19 May 2021
FDA: flexibility okay for gaps in gene therapy trials
18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy ...
Posted by Michael Wonder on 19 May 2021
Top FDA official says fully vaccinated people could need Covid booster shots within a year
18 May 2021 - COVID-19 booster shots could be needed for fully vaccinated people within a year, the FDA’s top ...
Posted by Michael Wonder on 19 May 2021
COVID-19 vaccines: In the rush for regulatory approval, do we need more data?
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
Posted by Michael Wonder on 18 May 2021
Essilor receives FDA breakthrough device designation for Essilor Stellest, its new generation of spectacle lens solutions in the fight against myopia
17 May 2021 - Essilor today announced that the U.S. FDA has granted breakthrough device designation to its Essilor Stellest spectacle ...
Posted by Michael Wonder on 18 May 2021
Biden pledges to export millions of FDA authorised vaccines
18 May 2021 - President says U.S. will have enough for entire population. ...
Posted by Michael Wonder on 18 May 2021
U.S. FDA accepts regulatory submission for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with non-squamous non-small cell lung cancer
18 May 2021 - Innovent Biologics and Eli Lilly today jointly announced that the U.S. FDA accepted for review a biologics ...
Posted by Michael Wonder on 17 May 2021
AffyImmune Therapeutics' AIC100 granted fast track designation for treating thyroid cancer
17 May 2021 - AffyImmune Therapeutics announced today that the US FDA granted fast track designation to its lead compound, AIC100, ...
Posted by Michael Wonder on 17 May 2021
Statement on leronlimab
17 May 2021 - FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment ...
Posted by Michael Wonder on 17 May 2021
US Supreme Court denies Sandoz petition to review biosimilar Erelzi (etanercept-szzs) case
17 May 2021 - Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable ...