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Showing 15 posts of 35 posts found.

EC approves Pfizer’s Litfulo for adolescents and adults with alopecia

September 19, 2023
Medical Communications Dermatology, EC, Litfulo, alopecia

Pfizer has announced that the European Commission (EC) has granted marketing authorisation to Litfulo (ritlecitinib) to treat adult and adolescent …

News

Merck’s Keytruda approved by EC for gastric cancer

August 30, 2023
Research and Development EC, Merck, Oncology, gastric cancer, keytruda

Merck (known as MSD outside of the US and Canada) has announced the approval of its gastric cancer treatment, Keytruda, …

News
biogen_austria_238

Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

June 28, 2021
Sales and Marketing EC, EMA, EU, biosimilars

Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

News
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Sanofi’s NSCLC drug gains EC approval

June 25, 2021
Medical Communications EC, EU, NSCLC, Sanofi

The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor, Libtayo (cemiplimab), for the first-line treatment of adults with …

News
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MHRA approves venetoclax as acute myeloid leukemia treatment

June 8, 2021
Manufacturing and Production EC, EU, MHRA, leukemia

The MHRA has announced its approval for AbbVie’s venetoclax, in combination with a hypomethylating agent, for the treatment of newly …

News

GW Pharma’s cannabidiol gains EC approval

April 21, 2021
Research and Development EC, EU, cannabis

GW Pharmaceuticals has received European Commission (EC) approval for the type II variation application for Epidyolex (cannabidiol), as an adjunctive …

News
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Celltrion’s inflammatory disease drug Yuflyma gets EU approval for 13 indications

February 16, 2021
Manufacturing and Production EC, celltrion

The European Commission (EC) has granted marketing authorisation for Celltrion’s Yuflyma, an adalimumab biosimilar, across all thirteen intended indications for …

News
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Roche’s influenza drug Xofluza gets EU approval

January 11, 2021
Sales and Marketing EC, Roche, influenza

The European Commission (EC) has approved Roche’s Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 …

News
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Pharmafile.com’s weekly COVID-19 news round-up

November 6, 2020
Medical Communications COVID, COVID-19, EC, FDA, coronavirus

The top ten news stories this week focus on regulatory approvals as the European Commission has approved GlaxoSmithKline’s Zeljula as …

News
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European Commission approves first drug for hepatitis D

August 6, 2020
Business Services EC, hepatitis C, hepatitis D

The European Commission has approved Heplcudex (bulvirtide) as the first hepatitis D drug. It was jointly developed by researchers at …

News
ebola_vaccine

European Commission announces approval for Janssen’s Ebola vaccine

July 2, 2020
Business Services EC, Ebola, Ebola Vaccines

Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen Ebola vaccine. Two Marketing Authorisation …

News

Ameluz approved by European Commission for treatment for actinic keratosis

March 11, 2020
Research and Development EC, EMA, Europe, Lesions

Biofrontera AG has announced the European Commission has approved the use of their drug Ameluz in combination with photodynamic therapy …

News
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AbbVie granted EU marketing authorisation for new arthritis drug

December 19, 2019
Business Services AbbVie, EC, EU, arthritis, rheumatoid arthritis

AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible …

News
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Roche scores two EU approvals in haemophilia and rare autoimmune disease

March 15, 2019
Medical Communications EC, EU, Europe, Roche, haemophilia, rare diseases

The European Commission (EC) has approved Roche’s haemophilia treatment Hemlibra (emicizumab). The approval comes as the EC approved Roche’s MabThera …

News

Novo’s Ozempic secures European approval in type 2 diabetes

February 12, 2018
Sales and Marketing EC, EMA, Europe, Novo Nordisk, diabetes, pharma

Novo Nordisk has revealed that its drug Ozempic (semaglutide) has received approval from the European Commission (EC) as a monotherapy …

News

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