EMA News | iPharmaCenter

Novartis’ Kisqali Gains European Commission Approval for Broader Use in Early Breast Cancer Patients at High Risk of Recurrence | iPharmaCenter

The European Commission (EC) has approved Kisqali (ribociclib) in combination with aromatase inhibitors (AI) for the treatment of...

EMA Drug Approvals 2024 | CHMP Positive Opinion | October 2024 | iPharmaCenter

Alhemo recommended for European approval as first daily subcutaneous prophylactic treatment for haemophilia A or B patients with...

European Commission Greenlights Keytruda and Padcev Combo as First-Line Treatment for Advanced Urothelial Carcinoma | iPharmaCenter

Merck's Keytruda (pembrolizumab), combined with Padcev (enfortumab vedotin), has received approval from the European Commission (EC) as a...

European Commission Expands Approval for GSK's Arexvy, the First RSV Vaccine for Adults Aged 50-59 at Increased Risk | iPharmaCenter

In a significant development, the European Commission has expanded the approval of Arexvy, GSK's respiratory syncytial virus (RSV)...

Roche aims PNH market with SC PiaSky, aims to target AZ's Ultomiris market | iPharmaCenter

EU Approval for Roche’s PiaSky as First Monthly Subcutaneous Treatment for PNH Roche has announced that the European Commission has...

European Union Approves Ordspono for Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma | iPharmaCenter

Regeneron Pharmaceuticals has announced that the European Commission (EC) has granted approval for Ordspono (odronextamab) for the...

Leqembi (lecanemab) Approved in Great Britain for Early-Stage Alzheimer's Disease | iPharmaCenter

Great Britain has granted approval for Leqembi (lecanemab), a treatment designed for adults with mild cognitive impairment (MCI) and...

The European Commission Grants Approval for Tepkinly for a New Indication in Treating Relapsed/Refractory Follicular Lymphoma in Adults | iPharmaCenter

Tepkinly (epcoritamab) has received conditional marketing authorization from the European Commission (EC) as a monotherapy for treating...

Dupixent (Dupilumab) Gains EU Approval as the First Targeted Therapy for COPD

Regeneron Pharmaceuticals and Sanofi announced that the European Commission (EC) has granted approval for Dupixent (dupilumab) as an...

Lynparza and Imfinzi Combination Recommended for EU Approval by CHMP for Advanced or Recurrent Endometrial Cancer AstraZeneca announced...

European Commission Approves Roche's Alecensa as First Targeted Adjuvant Therapy for Early-Stage ALK-Positive Lung Cancer | 2024 | iPharmaCenter

Roche announced that the European Commission has approved Alecensa (alectinib) as the first targeted adjuvant treatment for adults with...

Biogen Gains European Commission Approval for QALSODY (tofersen), a Novel Therapy for a Rare Genetic Form of ALS | EMA Drug Approvals | 2024 | iPharmaCenter

Biogen has announced that the European Commission (EC) has granted marketing authorization for QALSODY (tofersen), marking the first...

EMA Drug Approvals | Europe drug approvals | 2024 | iPharmaCenter

January 08, 2024 EC approved Rystiggo for gMG UCB has received approval from the European Commission (EC) for Rystiggo (rozanolixizumab)...

EMA Drug Approvals - CHMP Positive Opinions | March 2024 | iPharmaCenter

Novartis' Fabhalta Receives Favorable CHMP Opinion for PNH Treatment Advancement UCB's Bimzelx (bimekizumab) garners favorable CHMP...

CHMP Positive Opinions | February | 2024 | iPharmaCenter

Voydeya Received CHMP Position Opinion for Residual Haemolytic Anaemia for PNH The CHMP of the European Medicines Agency (EMA) has...

Medicines and Healthcare products Regulatory Agency | UK Drug approvals | News | iPharmaCenter

November 16, 2023 UK Grants First-Ever Approval for CRISPR/Cas9 Gene-Edited Therapy, CASGEVY, in Sickle Cell Disease and Thalassemia...

EMA Drug Approvals | CHMP Positive Opinions in October 2023 | Europe drug approvals | iPharmaCenter

NEW DRUG APPROVALS Santhera Pharmaceuticals' Agamree received CHMP's positive opinion for DMD. Santhera Pharmaceuticals has received a...

Drug approvals in Europe| EMA drug approvals | 2023 |European Commission News| iPharmaCenter

European Commission (EC) has granted conditional marketing authorization for AbbVie's Tepkinly (epcoritamab) as a standalone treatment...

CHMP Positive Opinions | EMA Drug Approvals | European Commission | 2023 | iPharmaCenter

JULY 2023 CHMP POSITIVE OPINIONS The EMA's CHMP gave a positive opinion for ViiV Healthcare's cabotegravir, marking a significant...

Switzerland drug approvals | Swissmedic news | Blogs | 2023 | iPharmaCenter

Medicines and Healthcare products Regulatory Agency | News | 2023 Approvals | iPharmaCenter

Eisai and Biogen have jointly announced the submission of a Marketing Authorization Application (MAA) for lecanemab, an investigational...

DECEMBER 2022 CHMP POSITIVE OPINIONS CSL's gene therapy, Hemgenix, received a positive CHMP opinion for treating Hemophilia B. The CHMP...

Drug approvals in Europe| EMA drug approvals in 2022 |European Commission News| iPharmaCenter

December 21, 2022 EMA approved Lynparza, Zytiga, and prednisone or prednisolone combination for metastatic castration-resistant prostate...

France healthcare News | HAS Sante | COVID 19 | Drug approvals | iPharmaCenter

December 08, 2022 Sanofi/GSK's and Novavax's COVID-19 vaccine received a favorable opinion from HAS as a booster dose vaccine. HAS...

COVID19 drug updates | FDA EMA approved COVID19 drugs

Oct 6, 2022 Merck and Ridgeback announced that molnupiravir has no efficacy in vaccinated adults. Merck and Ridgeback announced two...

Opdualag was approved for unresectable/metastatic melanoma | LAG-3 inhibitors | Mode of action

Bristol Myers Squibb announced that the European Commission had approved Opdualag (nivolumab and relatlimab) for treating advanced...

European Commission approved Scemblix for chronic myeloid leukemia | iPharmaCenter

European Commission has approved Scemblix (asciminib) for treating adult patients with Philadelphia chromosome-positive chronic myeloid...

Roche’s Polivy was approved as first-line therapy for patients with DLBCL.

Roche has announced that the European Commission approved Polivy (polatuzumab vedotin) in combination with rituximab plus...

Germany HTA News | IQWIG and G-BA assessment news | Germany Pharma News

December 2021 IQWIG says Rinvoq has added benefit at higher doses, but with safety issues IQWIG has assessed the benefit assessment of...

European Commission approved Roche's and Celltrion's monoclonal antibodies for COVID19

Ronapreve (casirivimab / imdevimab) approved for treating and preventing COVID19 in adults and adolescents Celltrion's Regkirona...

European Commission approved Benlysta for active lupus nephritis

GlaxoSmithKline announced that it received approval for expanded use of Benlysta (belimumab) for lupus nephritis in Europe. The drug is...

France COVID-19 Updates | COVID-19 News in Europe

HAS recommended the user of mRNA vaccines for a population already administered with AstraZeneca vaccine AstraZeneca’s COVID19 vaccine...

GSK’s Jemperli received approval in Europe and the US for endometrial cancer

GSK has announced that the US FDA has approved Jemperli (dostarlimab), a programmed death receptor-1 (PD-1) for endometrial cancer. The...

England patients to benefit from Phesgo, 5-minute breast cancer treatment from Roche

NHS England recommended the use of Roche's Phesgo (pertuzumab/trastuzumab) for treating HER2-positive breast cancer. HER2-positive breast...

CHMP Opinions | EMA drug approvals

March 2021 CHMP Positive Opinion Verastem’s Copiktra (duvelisib) received CHMP positive opinion for treating CLL and FL CHMP gave a...

Novartis and BeiGene collaboration strengthens the Swiss drugmaker's oncology portfolio

Novartis entered a strategic collaboration with BeiGene to license tislelizumab; to market in major markets outside China, including...

Biogen initiated Phase 4 trial to determine the efficacy of Spinraza in Zolgensma treated patients

Biogen has announced that the first patient with spinal muscular atrophy (SMA) has been treated with Spinraza (nusinersen), who were...

Kite’s CAR-Tcell therapy received approval in Europe for relapsed or refractory mantle cell lymphoma

Kite announced that it received conditional approval in Europe for Tecartus (brexucabtagene autoleucel). Tecartus is a chimeric antigen...

European Commission to purchase 200 million doses of Johnson and Johnson's COVID 19 vaccine

Johnson and Johnson announced that the European Commission had approved an Advance Purchase Agreement, according to which the European...

HAS says Gilead's Veklury 'does not improve benefit' for COVID19 patients; EMA to review safety

HAS announced that Gilead has withdrawn the refund request of Veklury (remdesivir) for COVID19 patients. Also read: HEALTHCARE SYSTEM IN...

ESMO 2020

BMS Opdivo for Resected Esophageal or Gastroesophageal Junction Cancer Bristol Myers Squibb has presented the results of Phase 3...

Oxford vaccine trials were paused because of safety concerns; AZ said it’s ‘routine’

AstraZeneca has announced that the randomized clinical trials of AZD1222, a vaccine developed Oxford, has been paused because of the...

European Commission approved GSK’s Blenrep for relapsed and refractory multiple myeloma

GSK has announced that the European Commission has granted approval for Blenrep (belantamab mafodotin) for treating adult patients with...

JULY 2020 CHMP POSITIVE OPINION

ADAKVEO (crizanlizumab) Adakveo received a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) for...

European Commission approved Lynparza for metastatic pancreatic cancer

AstraZeneca and Merck have announced that they have received the approval of Lynparza (Olaparib) for germline BRCA-mutated metastatic...

Gilead’s Veklury received conditional marketing authorization from the European Commission

Gilead Sciences has announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) for...

European Commission approved Janssen's Ebola vaccine

Johnson and Johnson announced that the European Commission had approved the Ebola vaccine to prevent the Ebola virus disease. Janssen has...

GSK and Clover Biopharmaceuticals begins COVID-19 vaccine Phase 1 clinical trial

GSK has announced that Clover Biopharmaceuticals initiated the Phase 1 trial of COVID-19 vaccine SCB-2019. The vaccine was given in...

Governments and other organizations raised US$ 8.8 billion at Global Vaccine Summit

The Global Vaccine Summit hosted in the UK was successful in raising US$ 8.8 billion, more than the expected target of US$ 7.4 billion....

#EULAR2020

JANSSEN TREMFYA Janssen has presented new data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2 of Tremfya (guselkumab), in...