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Moderna files CMA to EMA for mRNA 1273 booster dose in COVID-19

Written by | 8 Sep 2021

Moderna announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19… read more.

Moderna announces submission of initial data to the FDA for mRNA-1273 at the 50 µg dose level

Written by | 7 Sep 2021

Moderna, Inc., announced it has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg… read more.

FDA approves Amplatzer Amulet Device to treat people with atrial fibrillation at risk of stroke – Abbott

Written by | 3 Sep 2021

Abbott has announced that the FDA approved the company’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic… read more.

FDA approves Ticovac for tick-borne encephalitis – Pfizer

Written by | 2 Sep 2021

Pfizer Inc. announced that the FDA has approved Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. Ticovac… read more.

European Commission approves Evrenzoto treat adult patients with symptomatic anemia associated with chronic kidney disease – Astellas + FibroGen Inc.

Written by | 1 Sep 2021

Astellas Pharma Inc.and FibroGen, Inc. announced that the European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney… read more.

Pfizer and BioNTech announce submission of initial data to FDA to support booster dose of COVID-19 Vaccine

Written by | 31 Aug 2021

Pfizer Inc. and BioNTech SE announced that they have submitted Phase 1 data to the FDA to support the evaluation of a third, or booster, dose of the… read more.

Rydapt receives NICE recomendation to treat agressive systemic mastocytosis – Novartis

Written by | 30 Aug 2021

Novartis welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination recommending Rydapt (midostaurin) for the treatment of aggressive… read more.

FDA updates emergency use authorisation for mRNA 1273 in COVID-19 – Moderna

Written by | 29 Aug 2021

Moderna announced that the FDA has approved an update to the emergency use authorization for the Moderna mRNA 1273 COVID-19 vaccine to include a third dose for immunocompromised… read more.

FDA approves Jardiance to treat adults living with heart failure with reduced ejection fraction – Boehringer Ingelheim + Eli Lilly

Written by | 27 Aug 2021

Jardiance (empagliflozin) 10 mg has been approved by the FDA to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with… read more.

Ronapreve, the first monoclonal antibody treatment for COVID-19 approved for use in the UK – Regeneron + Roche

Written by | 26 Aug 2021

Following on from a thorough review of the evidence carried out by the MHRA, and recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific… read more.

EU approves Abecma for multiple myeloma – BMS

Written by | 23 Aug 2021

Bristol Myers Squibb announced that the European Commission has granted Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)… read more.

FibroGen receives Complete Response Letter from the FDA for roxadustat for anemia of chronic kidney disease – FibroGen + AstraZeneca

Written by | 22 Aug 2021

The FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in… read more.

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