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 ...
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 ...
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 ...
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 ...
Medscape5d
EMA Approves AI Tool for MASH Clinical Trials
The tool reduces pathologist variability in liver biopsy assessment during trials of treatments for metabolic ...
Pharmabiz13h
EMA committee recommends approval of Bristol Myers Squibb’s subcutaneous formulation of Opdivo across multiple solid tumour indications
EMA committee recommends approval of Bristol Myers Squibb’s subcutaneous formulation of Opdivo across multiple solid tumour indications: Princeton, New Jersey Monday, March 31, ...
PharmiWeb9h
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously ...
Curis targets accelerated approval for emavusertib in PCNSL with 12-18 month enrollment timeline
Discover key insights from Curis, Inc.'s Q4 2024 earnings call, highlighting promising trial results, regulatory alignment, and extended financial runway.
Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to UK MHRA
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory ...
pharmaphorum4d
Takeda dengue vaccine receives positive CHMP opinion
Approval from the EMA is expected within months ... on the use of the medicine within their countries. The CHMP’s positive opinion of TAK-003 was supported by results across five phase 1 ...