EMA proposes modifying pre-existing clinical trials during public health emergencies Pre-existing clinical trials should be adapted during public health emergencies, draft guidance from the Accelerating Clinical Trials in the EU (ACT EU) initiative has said. The guidance, published…

Draft #EMA guidance says pre-existing clinical trials should be adapted during public health emergencies

#publichealth #clinicaltrials #europeanmedicinesagency

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EMA and FDA set common principles for AI in medicine development | European Medicines Agency (EMA) Advancing safe, ethical and aligned AI practices across the medicines lifecycle

The #EuropeanMedicinesAgency & the #FoodandDrugAdministration have established common principles for #artificialintelligence use in #medicine #development, aiming to manage AI's #potential & #risks. www.ema.europa.eu/en/news/ema-...

Prefilled Syringe Presentation of GSK’s SHINGRIX Receives Positive CHMP Opinion On October 21, 2025, GSK announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for the shingle vaccine SHINGRIX (reco...

Prefilled Syringe Presentation of GSK’s SHINGRIX Receives Positive CHMP Opinion

#Vaccine #EuropeanMedicinesAgency #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/03/p...

Moderna wins EU approval for updated COVID-19 vaccine - PharmaTimes Spikevax authorised to target LP.8.1 variant ahead of 2025-2026 season

#vaccines #Moderna #COVID19vaccine #Spikevax #LP81variant #marketingauthorisation #updatedCOVID19vaccine #SARSCoV2variantLP81 #EuropeanMedicinesAgency #EMA #20252026vaccinationseason #eligiblepopulations #globalhealthauthorities #ModernaCOVID19vaccines
pharmatimes.com/news/moderna...

Sign still up. A sad relic to the stupidity of a country that threw it all away entirely of its own volition. #europeanmedicinesagency #ema #brexit #canarywharf

Rxulti approved in the European Union for adolescent schizophrenia - PharmaTimes EC extends brexpiprazole indication to include adolescents

#mentalhealth #Rxulti #adolescentschizophrenia #schizophrenia #adolescenceonsetschizophrenia #brexpiprazole #typicaloralantipsychotic #antipsychotic #OtsukaPharmaceuticalEurope #Lundbeck #schizophreniainadolescents #CHMP #CHMPapprovel #EuropeanMedicinesAgency
pharmatimes.com/news/rxulti-...

Orphelia Pharma explores other pathways for paediatric cancer treatment - PharmaTimes Company seeks new direction after negative CHMP opinion on KIZFIZO

#OrpheliaPharma #KIZFIZO #CHMP #EuropeanMedicinesAgency #CHMPdecision #neuroblastoma #compassionateuse #earlyaccessprograms #clinicaltrials #temozolomideoralsuspension #EarlyAccessAuthorisation #OrphanDrugDesignation #TEMOkidsstudy #BEACONChemostudy #RetroTMZstudy
pharmatimes.com/news/orpheli...

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📢 New Editorial in @drugsincontext.bsky.social by our Associate Editor Rajesh Tampi

Lecanemab for mild Alzheimer disease – is there a way forward?

www.drugsincontext.com/lecanemab-fo...

#drugsincontext #alzheimers #geriatrics #psychiatry #pharmacology #EuropeanMedicinesAgency #lecanemab #MedSky

➡️ @ema.europa.eu

USE / TAP #️⃣😉
#News
#Reuters
#EMA
#EuropeanMedicinesAgency

Seeking new social media horizons, EMA joins mass migration from X to Bluesky As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines Agency (EMA) has embarked on its own metamorphosis from one text-based | A...

USE / TAP #️⃣😉
#News
#EMA
#EuropeanMedicinesAgency
#Bluesky

@ema-eu.bsky.social

www.fiercepharma.com/marketing/em...

FDA approves durvalumab for limited-stage small cell lung cancer - OncoDaily FDA approves durvalumab for limited-stage small cell lung cancer / Australian Therapeutic Goods Administration, Brazilian Health Regulatory Agency, Byoung

FDA approves durvalumab for limited-stage small cell lung cancer

oncodaily.com/blog/fda-198...

fda.gov

#Cancer #Durvalumab #EuropeanMedicinesAgency #FDA #Health #OncoDaily #Oncology #SmallCellLungCancer

Ooops. #EMA #EuropeanMedicinesAgency