AstraZeneca’s Koselugo (selumetinib) has been granted conditional approval in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. 22 June 2021
The European Commission (EC) has granted full Marketing Authorization for Onureg (azacitidine tablets; CC-486), US pharma major Bristol Myers Squibb announced on Friday. 21 June 2021
The European Union Council has reached an agreement on draft rules to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. 16 June 2021
Notes from the June meeting of the European Medicines Agency’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with AstraZeneca’s coronavirus vaccine. 11 June 2021
The European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM), US pharma major Bristol Myers Squibb (NYSE: BMY) announced yesterday. 3 June 2021
Targeted therapies have been a game changer in EGFR-mutated lung cancer, with options such as Tagrisso (osimertinib), from AstraZeneca, helping to greatly improve progression-free survival (PFS). 28 May 2021
The European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 26 May 2021
Johnson & Johnson subsidiary Janssen has received approval from the European Commission for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. 25 May 2021
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. 21 May 2021
Following its May 2021 meetings, the European Medicines Agency’s human medicines committee (CHMP) recommended eight even medicines, including one gene therapy and one generic, for approval. 21 May 2021
New storage conditions for the COVID-19 vaccine from Pfizer and Germany’s BioNTech have today been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 21 May 2021
US biotech Vertex Pharmaceuticals says that the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have validated the post-marketing applications for an expanded indication of Kaftrio. 20 May 2021
Slow progress in preparing regulatory submissions will see US vaccines developer Novavax send its COVID-19 vaccine, NVX-CoV2373, for approval in the third quarter at the earliest. 11 May 2021
The European Commission (EC) has approved an additional indication for the oral once-daily therapy Xtandi (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC), says Japanese drug major Astellas Pharma. 10 May 2021
Minutes from the May meeting of the European Medicines Agency’s safety committee show the panel has reaffirmed the positive benefit-risk ratio of approved coronavirus vaccines. 7 May 2021
The European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. 7 May 2021
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. 7 May 2021
European authorities have granted marketing authorization for a new indication for Tecentriq (atezolizumab), the checkpoint blocker developed by Roche. 5 May 2021
The European Commission (EC) has granted marketing authorization to ADV7103 (potassium citrate/potassium hydrogen carbonate), proposed trade name Sibnayal, for the treatment of distal renal tubular acidosis (dRTA), says French biotech Advicenne. 4 May 2021
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech being spun out of Hong Kong-listed GenScript Biotech, revealed on Friday that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma. 1 May 2021
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