At its November 11-14 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five novel medicines for marketing approval. 16 November 2019
The European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycemic control in adults with type-2 diabetes (T2D), says Cambridge, UK-based AstraZeneca 15 November 2019
Actelion Pharmaceuticals has decided to voluntarily withdraw the European and other health authority filings still under review to extend the indication of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). 13 November 2019
US pharma giant Merck has revealed that the European Commission has granted a conditional marketing authorization to Ervebo for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. 12 November 2019
Janssen, the pharmaceutical arm of American drugmaker Johnson & Johnson, has applied for European approval for its investigational Ebola vaccine regimen. 7 November 2019
The European Medicines Agency (EMA) has validated for review Pierre Fabre’s filing of Type II variation applications for Braftovi (encorafenib) and Mektovi (binimetinib) in combination with cetuximab for BRAFV600E-mutant metastatic colorectal cancer (mCRC). 6 November 2019
European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage. 31 October 2019
The European Medicines Agency has validated the Marketing Authorization Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it accelerated assessment. 30 October 2019
The European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity. 30 October 2019
The European Commission (EC) today approved a new indication for Dupixent (dupilumab) in chronic rhinosinusitis with nasal polyposis (CRSwNP). 29 October 2019
Merck KGaA and Pfizer’s entry into the PD-L1 space has secured a European Commission approval in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). 29 October 2019
There was good news today for Shanghai-based WuXi AppTec subsidiary WuXi STA Pharmaceutical, with the announcement that its Jinshan manufacturing facility in Shanghai, China, has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings. 28 October 2019
The Amsterdam headquarters of the European Medicines Agency hosted an important meeting between European and Chinese medicines regulators on Friday. 25 October 2019
The European Commission (EC) has approved the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+), Japanese drug major Astellas Pharma announced this morning. 25 October 2019
Clinical-stage biotech Provention Bio today announced the European Medicines Agency has granted PRV-031 (teplizumab) PRIority MEdicines (PRIME) designation for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. 24 October 2019
Maurits Lugard and Anna-Shari Melin from law firm Sidley Austin provide an Expert View on the European Medicines Agency’s (EMA) recent guidance on medicinal product shortages and implications of this guidance. 24 October 2019
The European regulator has agreed to expand the label for Cosentyx (secukinumab), to include a higher dosage level of 300mg for people with active ankylosing spondylitis (AS). 24 October 2019
A Type II variation application has been submitted to the European Medicines Agency (EMA) seeking approval for Tremfya (guselkumab) to treat adults with active psoriatic arthritis (PsA). 23 October 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