Medscape5d
EMA Approves AI Tool for MASH Clinical Trials
The tool reduces pathologist variability in liver biopsy assessment during trials of treatments for metabolic ...
The Pharma Letter2d
March 2025 EMA/CHMP meeting new drug opinions
The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three ...
Medical Dialogues1d
Bristol Myers Squibb receives positive EMA Committee opinion for Perioperative Opdivo plus Chemo in Resectable Non-Small Cell Lung Cancer plus PD-L1
Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Yahoo Finance20d
MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013
Positive EMA Pediatric Committee opinion has cleared the investigation clinical plan to evaluate the safety and efficacy of MaaT013 in patients from 6 years old to less than 18 years old with ...
Medical Dialogues2d
Bristol Myers Squibb gets Positive EMA Committee opinion for subcutaneous formulation of Opdivo across Multiple Solid Tumor Indications
Princeton: Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ...
pharmaphorum15d
EMA recommends Lundbeck’s alcohol dependency drug for approval
Specialised drug development company, Biotie, has announced that its partner Lundbeck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European ...
The Bakersfield Californian28d
Ocugen Announces Positive Opinion of EMA’s Committee for Advanced Therapies for ATMP ...
GA affects 2-3 million people in the United States (U.S.) and Europe combined. There are two approved therapies in the U.S. that require frequent dosing (every month or every other month), however ...
Hosted on MSN27d
Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug
Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use ...
AstraZeneca’s Calquence recommended for approval in EU for treatment of MCL
Calquence in combination with bendamustine and rituximab has been recommended for approval in the European Union, EU, for ...
Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications
Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications ...