FDA grants Orphan Drug Designation to phenylketonuria treatment
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.
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Limited supply of antimalarial drugs may prevent use against COVID-19, say doctors
An open letter from doctors highlights that although chloroquine and hydroxychloroquine are strong candidates to fight COVID-19, there is a limited supply.
COVID-19 convalescent plasma therapy shows promise in pilot study
A pilot trial of convalescent plasma therapy in 10 severe COVID-19 patients has shown it may be a safe and promising therapeutic option.
Pharma programmes for employees to volunteer in fight against COVID-19
Lilly, Merck and Pfizer have announced how they will enable their employees to volunteer in programmes to combat COVID-19 while on base pay.
EMA recommendations on compassionate use of remdesivir for COVID-19
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
Using fatty acids in oral formulations to improve drug delivery
Researchers have used triglyceride fatty acids to develop an oral formulation for drugs that are usually injected or taken intravenously.
India to import PPE from China in COVID-19 fight, says report
New reports say that India will stock up on personal protective equipment and ventilators by banning exports and importing from China.
COVID-19 Clinical Research Coalition to accelerate coronavirus R&D in resource-poor countries
The coalition has been formed to find R&D solutions for low- and middle-income countries to limit the impact of the COVID-19 pandemic in areas with fragile healthcare systems.
Novel microneedle array developed to deliver COVID-19 vaccine to mice
Researchers have created a microneedle array that successfully delivered a COVID-19 vaccine to mice, allowing them to produce antibodies against the virus.
Francis Crick Institute and collaborators to offer COVID-19 testing for key workers
The institute has paused cancer research and repurposed its laboratories and scientists to provide a rapid COVID-19 testing facility for NHS staff and other key workers.
EMA releases its regulatory strategy for next five years
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
Dr Reddy’s recalls four lots of Phytonadione injectable emulsion in US
The FDA has announced that Dr Reddy's is recalling Phytonadione injectable emulsion because of complaints due to ampules breaking and shattering.
Influenza antiviral Avigan® (favipiravir) to enter Phase III trials in COVID-19 patients
The developers of Avigan have increased production and announced a Phase III clinical trial testing its efficacy against COVID-19.
Two Phase III trials to study remdesivir in COVID-19 patients initiated
Gilead Sciences has announced that two Phase III studies to test the safety and efficacy of remdesivir in COVID-19 patients have begun.
FDA requests recall of all ranitidine products on US market
The US FDA has announced that all manufacturers should withdraw their ranitidine products from the market due to the risks associated with NDMA impurities.
