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FDA approves first-in-human trial of COVID-19 vaccine candidate
The safety and immunogenicity of CORVax12, a novel DNA-encodable COVID-19 vaccine, will be evaluated in 36 healthy volunteers.
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US Food and Drug Administration (FDA)
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US to receive 300,000 vials of experimental COVID-19 antibody therapy
Eli Lilly will provide the US government with vials of its COVID-19 antibody therapy bamlanivimab (LY-CoV555) if the treatment is granted Emergency Use Authorisation.
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Clinical trials to study AstraZeneca’s COVID-19 vaccine resume globally
Clinical trials for AZD1222, the AstraZeneca COVID-19 vaccine candidate, have resumed across the world after confirmation it is safe to do so.
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Trial to evaluate oral nitric oxide therapy in COVID-19 patients
The study will establish whether NOviricid can improve COVID-19 patient outcomes and survival in 840 recently diagnosed African American patients with comorbidities.
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Approval of regulatory starting materials
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
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FDA approves remdesivir for treatment of COVID-19
The FDA has given marketing authorisation for Veklury (remdesivir) to treat COVID-19 patients requiring hospitalisation.
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The FDA requires changes to NSAID labelling
The FDA is requiring that the prescribing information for nonsteroidal anti-inflammatory drugs (NSAIDs) include warnings about potential foetal kidney problems if taken by women over 20 weeks pregnant.
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US FDA approves the first Ebola virus treatment – Inmazeb
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
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J&J pauses COVID-19 vaccine clinical trial after participant illness
J&J has paused its Phase III trial for its COVID-19 vaccine candidate following an unexplained illness in a study participant.
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US enters agreement for experimental prophylactic COVID-19 antibody cocktail
The US government will develop and manufacture AstraZeneca’s investigational monoclonal antibody cocktail, AZD7442, a potential prophylactic treatment for COVID-19.
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FDA grants Orphan Drug Designation to two cancer treatments
The FDA has given small molecules APG-115 and APG-1252, two cancer treatments, Orphan Drug Designation.
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Eli Lilly provides update on COVID-19 antibody programmes
Eli Lilly has given an update on its neutralising antibody programmes, including its combination therapy in patients with COVID-19.
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FDA issues guidance for COVID-19 vaccine Emergency Use Authorizations
The FDA has released new guidance for sponsors regarding Emergency Use Authorizations for potential COVID-19 vaccines.
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SMA drug Zolgensma® has “significant therapeutic benefit”, according to interim data
Treatment with Zolgensma® (onasemnogene abeparvovec) resulted in rapid and sustained improvement in motor function in spinal muscular atrophy (SMA) patients.
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EUA requested for potential COVID-19 respiratory failure treatment
An Emergency Use Authorization (EUA) request for the use of RLF-100™ (aviptadil) in critical COVID-19 patients was submitted to the US FDA.
