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
Following October 14-17 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) today recommended seven medicines for approval. 18 October 2019
The Irish pharmaceutical industry has called for the European regulatory framework to be protected and strengthened for the biopharma sector. 7 October 2019
At its October 3, 2019 meeting in Amsterdam, Netherlands, the European Medicines Agency's Management Board was updated on the Agency’s ongoing preparations for the withdrawal of the UK from the European Union. 4 October 2019
The European Medicines Agency’s safety unit, the Pharmacovigilance Risk Assessment Committee (PRAC), has recommended limiting the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to four weeks. 4 October 2019
Swedish startup Lobsor Pharmaceuticals expects to complete registration in the Nordic region for its lightweight Parkinson’s disease therapy Lecigon (levodopa/carbidopa/entacapone) this month. 2 October 2019
Stockholm’s Calliditas Therapeutics has moved one step closer to securing European Medicines Agency (EMA) approval for its lead compound nefecon, the firm said in a statement on Monday. 1 October 2019
With nitrosamines impurities now identified in ranitidine and ‘sartan’ medicines, the European Medicines Agency’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. 26 September 2019
The European Commission has approved the marketing authorization for marijuana-based Epidyolex (cannabidiol) for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients aged two years and older. 23 September 2019
China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency 23 September 2019
As well as recommending approval of four novel medicines and three generic medicines at its September 2019 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced positive opinions for a number of label extensions, as follows: 23 September 2019
At its September meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of four novel medicines and three generic medicines. 20 September 2019
Ranitidine, the active ingredient of prescription and over-the-counter drug Zantac, originated by legacy company Glaxo but now available as a generic, has come under scrutiny by both the European Medicines Agency and the US Food and Drug Administration as a result of findings of contamination with a carcinogen. 14 September 2019
As incoming European Commission President Ursula von der Leyen prepares to take office at the end of next month, representatives from the pharmaceutical industry are stepping up lobbying efforts on behalf of the sector. 10 September 2019
Switzerland’s Roche has secured European approval for Tecentriq (atezolizumab), in combination with chemotherapy, for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). 6 September 2019
European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. 6 September 2019
The European medicines regulator has approved Lonsurf (trifluridine/tipiracil) for adults with metastatic gastric cancer, as a later-line option. 6 September 2019
Nearly a year after Merck & Co presented strong data for its Keytruda (pembrolizumab) combo in renal cell carcinoma (RCC), the firm has won approval in Europe. 4 September 2019
Shares of La Jolla Pharmaceutical (Nasdaq: LJPC) rose 5% pre-market yesterday after the company announced that the European Commission has approved Giapreza (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. 30 August 2019