Zacks Investment Research on MSN2d
CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo
Bristol Myers BMY announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of Opdivo (nivolumab) for another ...
Zacks Investment Research on MSN1d
PFE Secures EU Nod for Expanded Use of RSV Vaccine Abrysvo
Pfizer PFE announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its RSV ...
The Pharma Letter2d
EC refers lecanemab decision to Appeal Committee
Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) today provided an update on the ongoing regulatory review of the Marketing ...
Medscape8d
EMA Approves AI Tool for MASH Clinical Trials
The tool reduces pathologist variability in liver biopsy assessment during trials of treatments for metabolic ...
PMLive1d
BMS receives positive CHMP opinion for perioperative Opdivo regimen in lung cancer
Bristol Myers Squibb (BMS) has announced that its Opdivo (nivolumab) perioperative treatment regimen has been recommended by the European Medicines Agency’s human medicines committee for adults with ...
BeiGene receives positive CHMP opinion for Tevimbra
BeiGene (ONC) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion ...
BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the Committee for Medicinal Products for ...
Bristol Myers Gets CHMP Backing for Subcutaneous Opdivo
Bristol Myers Squibb said a key European regulatory committee is backing a formulation of its blockbuster cancer drug Opdivo that can be injected under the skin.
Medscape6d
Benefits Outweigh Risks for Weight Loss Drug Mysimba
The benefits of naltrexone/bupropion (Mysimba) continue to outweigh its risks, despite ongoing uncertainty about long-term ...
Halozyme: Bristol Myers receives positive CHMP opinion for Opdivo/Enhanze
Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products ...
PharmiWeb3d
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 ...
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 ...