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  • european-commission

Tag: European commission

You Searched For "european-commission"
European Commission approves indication extension of JnJ Imbruvica in frontline mantle cell lymphoma

J&J Imbruvica gains EU approval for untreated Mantle Cell Lymphoma in transplant eligible patients

Ruchika Sharma25 July 2025 12:40 PM IST
Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the European Commission (EC) has approved an...
Roche Itovebi gets European Commission nod

Roche Itovebi gets European Commission nod in fight against advanced breast cancer

Ruchika Sharma24 July 2025 2:30 PM IST
Basel: Roche has received approval from the European Commission for Itovebi (inavolisib), in combination with palbociclib (Ibrance) and...
JnJ Darzalex gets European Commission nod

JnJ Darzalex gets European Commission nod for high-risk smouldering multiple myeloma

Ruchika Sharma24 July 2025 12:15 PM IST
Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has received approval from the European Commission (EC) for a new...
Bayer Nubeqa gets EU approval

Bayer Nubeqa gets EU nod in third indication for advanced prostate cancer

Ruchika Sharma22 July 2025 10:30 AM IST
Berlin: Bayer has received marketing authorization from the European Commission in the European Union (EU) for Nubeqa (darolutamide), an oral...
Biocon appoints Ekta Agarwal as Interim Company Secretary, Compliance Officer

Biocon Biologics gets EU nod for bone disease treatments, including Osteoporosis, giant cell tumour of bone

Ruchika Sharma3 July 2025 11:29 AM IST
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has announced that the...
Aurobindo Pharma arm gets marketing authorisation for Zefylti in EU

Aurobindo Pharma arm gets marketing nod for Dazublys from European Commission

Ruchika Sharma2 July 2025 5:33 PM IST
Hyderabad: Aurobindo Pharma has announced that CuraTeQ Biologics, a wholly owned step-down subsidiary of the company, has obtained marketing...
Bayer gets UK nod for Lynkuet for moderate to severe vasomotor symptoms associated with menopause

Bayer Eylea 8 mg with extended 6-month treatment interval approved in EU for retinal diseases

Ruchika Sharma29 Jun 2025 11:00 AM IST
Berlin: Bayer has received approval from the European Commission (EC) for a label extension in the European Union (EU) for Eylea 8 mg...
Roche announces topline results from trials investigating astegolimab compared to placebo in COPD patients

Roche Evrysdi tablet gets European Commission approval for Spinal Muscular Atrophy

Ruchika Sharma5 Jun 2025 2:00 PM IST
Basel: Roche has announced that the European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new,...
Takeda gets USFDA 510(k) clearance for HyHub, HyHub Duo devices to simplify HYQVIA administration

Takeda Adcertris combo approved by European Commission for newly diagnosed Stage IIb/III/IV Hodgkin Lymphoma

Ruchika Sharma5 Jun 2025 11:30 AM IST
Osaka: Takeda has received approval from the European Commission (EC) for ADCETRIS (brentuximab vedotin) in combination with etoposide,...
USFDA updates Camzyos label to reduce echocardiography monitoring requirements, contraindications: Bristol Myers Squibb

Bristol Myers Squibb bags European Commission nod for Subcutaneous formulation of Opdivo across multiple solid tumor indications

Ruchika Sharma29 May 2025 10:00 AM IST
Princeton: Bristol Myers Squibb has received approval from the European Commission (EC) for a new Opdivo (nivolumab) formulation...
Bristol Myers Squibb bags European Commission approval for Opdivo combo in lung cancer treatment

Bristol Myers Squibb bags European Commission approval for Opdivo combo in lung cancer treatment

Ruchika Sharma18 May 2025 11:45 AM IST
Princeton: Bristol Myers Squibb has announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant...
AstraZeneca collaborates with CSPC Pharma focused on AI-enabled research

AstraZeneca Calquence plus chemoimmunotherapy approved in EU for 1st-line mantle cell lymphoma

Ruchika Sharma7 May 2025 12:30 PM IST
Cambridge: AstraZeneca has announced that Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the...
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