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Showing 15 posts of 39 posts found.

NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera

January 29, 2025
Sales and Marketing Duchenne Muscular Dystrophy, EC, EMA, FDA, Santhera Pharmaceuticals, positive

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to …

News

EC grants marketing authorisation to Sobi’s Altuvoct for haemophilia A treatment

June 19, 2024
Medical Communications Altuvoct, EC, EMA, Haematology, haemophilia a, sobi

Sobi has announced that the European Commission (EC) has granted marketing authorisation for Altuvoct (efanesoctocog alfa) for the treatment and …

News

EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease

March 13, 2024
Research and Development EC, EMA, Infections and infestations, Prevnar 20, pneumococcal disease

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Prevenar 20, the company’s 20-valent pneumococcal conjugate …

News

Daiichi Sankyo’s Vanflyta approved by EC for acute myeloid leukaemia treatment

November 10, 2023
Medical Communications Daiichi Sankyo, EC, EU, Oncology, Vanflyta, acute myeloid leukaemia

Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination use with standard cytarabine and …

News

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
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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
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Norgine enters exclusive licensing agreement with Vir Biotechnology

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Incyclix appoints Kimberly Blackwell to Board of Directors

December 17, 2025

Hansa Biopharma appoints Max Sakajja as Vice President, General Manager Europe and International

December 17, 2025

GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis

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