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RSS FeedPosted 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 ...
Posted by Michael Wonder on 17 May 2021
Biogen hopes Alzheimer’s drug mired in controversy earns FDA nod
13 May 2021 - After scores of failures, regulators are set to rule on aducanumab, which promises to slow dementia. ...
Posted by Michael Wonder on 17 May 2021
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA for the treatment of opioid overdose
17 May 2021 - Adamis Pharmaceuticals today announced that the new drug application was resubmitted to the U.S. FDA for ...
Posted by Michael Wonder on 15 May 2021
Apellis announces U.S. FDA approval of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria
14 May 2021 - Empaveli was superior to Soliris for the change from baseline in haemoglobin level at Week 16 in ...
Posted by Michael Wonder on 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...