During the ongoing Covid-19 pandemic, the FDA has continued in its normal role...
- When deadlines turn deadly: examining the psychology of drug regulators
- The US and the developing world: a tale of two opioid crises
- Covid-19 outbreak: pharma’s big players discuss pandemic response
- Covid-19 outbreak: delving into the UK Government’s official action plan
- Precision medicine: what barriers remain?
Russia grants temporary approval for Avifavir to treat Covid-19
The Ministry of Health of the Russian Federation has granted a temporary registration certificate to Covid-19 treatment, Avifavir, produced by the Russian Direct Investment Fund (RDIF) and the ChemRar Group.
UK grants early access to Gilead’s remdesivir for Covid-19
The UK Government has announced that some adults and adolescents hospitalised with Covid-19 on the National Health Service (NHS) will have access to Gilead Sciences' remdesivir.
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Novartis’ AveXis gets EC conditional approval for Zolgensma
Novartis subsidiary AveXis has received conditional approval from European Commission (EC) for Zolgensma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA).
AstraZeneca gets breakthrough status for Enhertu to treat NSCLC
AstraZeneca and its partner Daiichi Sankyo have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for Enhertu (trastuzumab deruxtecan) to treat non-small cell lung cancer (NSCLC).
How to launch a drug in a pandemic with Immunomedics
During the ongoing Covid-19 pandemic, the FDA has continued in its normal role of approving safe and effective drugs. But how do pharma companies go about bringing a new drug to market during the pandemic? Immunomedics’ chief commercial officer Brendan Delaney explains how his company has successfully facilitated the treatment of US patients with its first ever drug, Trodelvy, which was approved at the end of April.
Takeda receives China approval for Adcetris to treat lymphoma
Takeda China has received approval from the country's National Medical Products Administration (NMPA) for Adcetris (brentuximab vedotin) to treat relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma in adults.
FDA fast-tracks Moderna’s Covid-19 vaccine candidate
The US Food and Drug Administration (FDA) has awarded fast track designation to Moderna's mRNA vaccine candidate, mRNA-1273, developed to protect against Covid-19.
Lilly secures FDA approval for Retevmo to treat lung/thyroid cancers
Eli Lilly has secured accelerated approval from the US Food and Drug Administration (FDA) for the use of Retevmo (selpercatinib) to treat lung and thyroid cancers.
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