EC
NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera
January 29, 2025Sales 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 …
EC grants marketing authorisation to Sobi’s Altuvoct for haemophilia A treatment
June 19, 2024Medical 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 …
EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease
March 13, 2024Research 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 …
Daiichi Sankyo’s Vanflyta approved by EC for acute myeloid leukaemia treatment
November 10, 2023Medical 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 …
EC approves Pfizer’s Litfulo for adolescents and adults with alopecia
September 19, 2023Medical 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 …
Merck’s Keytruda approved by EC for gastric cancer
August 30, 2023Research 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, …
Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar
June 28, 2021Sales 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 …
Sanofi’s NSCLC drug gains EC approval
June 25, 2021Medical 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 …
MHRA approves venetoclax as acute myeloid leukemia treatment
June 8, 2021Manufacturing 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 …
GW Pharma’s cannabidiol gains EC approval
April 21, 2021Research 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 …
Celltrion’s inflammatory disease drug Yuflyma gets EU approval for 13 indications
February 16, 2021Manufacturing 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 …
Roche’s influenza drug Xofluza gets EU approval
January 11, 2021Sales 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 …
Pharmafile.com’s weekly COVID-19 news round-up
November 6, 2020Medical 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 …
European Commission approves first drug for hepatitis D
August 6, 2020Business 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 …
European Commission announces approval for Janssen’s Ebola vaccine
July 2, 2020Business Services EC, Ebola, Ebola Vaccines
Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen Ebola vaccine. Two Marketing Authorisation …
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