Sponsors of clinical trials run in the European Union have been reminded of their obligation to publish summaries of results in the EU Clinical Trials Database (EudraCT). 3 July 2019
The European Commission’s approval of Dovato (dolutegravir/lamivudine) has been hailed as an important milestone for HIV patients because this therapy offers a different option to three-drug regimens. 3 July 2019
The European Medicines Agency (EMA) is seeking to ensure that its regulatory processes keep pace with the innovation and change going on in the drug development industry. 2 July 2019
At its June meeting, the European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) issued recommendations on three medicines for approval, plus a negative opinion and some indications extensions. 28 June 2019
US biopharma Titan Pharmaceuticals has clocked up a third major market approval for an opioid dependence substitutional treatment that it developed. 27 June 2019
The European Commission (EC) has granted marketing authorization for Doptelet (avatrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. 27 June 2019
Swiss drugmaker Santhera Pharmaceuticals has had its marketing authorization application (MAA) accepted for Puldysa (idebenone) to treat respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) who are not using glucocorticoids. 25 June 2019
Some eight months after gaining marketing clearance for the drug in the USA, and an April advisory committee recommendation in Europe, US pharma giant Pfizer has now also won approval for Talzenna (talazoparib) in the European Union. 24 June 2019
Medicines for Europe, a group representing the European generic and biosimilar industries, has responded to a recent European Council declaration on good healthcare access, stating the industry is “ready to engage with the EU” to improve access to medicines. 21 June 2019
Fosun Pharma’s Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02 21 June 2019
Danish diabetes care giant Novo Nordisk announced late yesterday d that the European Commission has granted marketing authorization for Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of adolescents (≥12 years of age) and adults with hemophilia A. 21 June 2019
Shares in UK-based drugmaker AstraZeneca were up over 1% in early trading on Tuesday morning, after the firm announced European approval for Lynparza (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. 18 June 2019
At the meeting of the European Medicines Agency’s (EMA) management board last week, the topic of the move to Amsterdam and its impact on business and staff, along with other Brexit-related business, dominated the agenda. 17 June 2019
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) stated following its June 11-14 meeting that it has started a review of leuprorelin medicines. 14 June 2019
Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration, effective June 10. 12 June 2019
Denmark-based allergy specialist ALK-Abelló says it has successfully completed the marketing authorization procedure for its tree sublingual allergy immunotherapy (SLIT) tablet in 17 European countries. 8 June 2019
Celgene has provided cause for celebration for Bristol-Myers Squibb, which is set to take over the US biotech company, and its partner Acceleron Pharma. 5 June 2019
The European Commission (EC) has granted conditional marketing authorization for gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene). 4 June 2019
Vertex Pharmaceuticals says it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). 31 May 2019
Mitsubishi Tanabe Pharma announced today the withdrawal of the Marketing Authorization Application (MAA) of Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). 30 May 2019
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Following a positive a positive European Medicines Agency recommendation in July, the European Commission (EC) has now approved Yuvanci (macitentan 10mg and tadalafil 40mg single tablet combination therapy [M/T STCT]). 1 October 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
The European Medicines Agency’s (EMA) safety committee (PRAC) has recommended measures to minimize serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. 7 September 2024
EC approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for urothelial carcinoma in adults. 3 September 2024
Pierre Fabre Laboratories has announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. 30 August 2024
The European Commission has authorized GSK's (LSE: GSK) Arexvy (respiratory syncytial virus vaccine) for preventing lower respiratory tract disease caused by RSV in adults aged 50-59 with underlying health conditions. 30 August 2024
The European Commission (EC) has extended the indications of the antifungal Cresemba (isavuconazole) to pediatric patients, says Swiss drugmaker Basilea Pharmaceutica. 28 August 2024
The European Commission (EC) has approved a Type II extension of indication for Johnson & Johnson’s Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed). 27 August 2024
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
US biotech Regeneron Pharmaceuticals yesterday announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. 27 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) 27 August 2024