The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including six orphan medicines, and two CAR-T therapies, at its June 2018 meeting. 29 June 2018
The European Commission (EC) has approved Dzuveo (sufentanil sublingual tablet; under development in the USA as Dsuvia) for the management of acute moderate to severe pain in adults in medically monitored settings. 27 June 2018
The European Commission has granted marketing authorization for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. 25 June 2018
US biotech major Amgen yesterday announced that the European Commission (EC) has granted a full marketing authorization for Blincyto (blinatumomab) based on the overall survival (OS) data from the Phase III TOWER study. 20 June 2018
Privately-held Viennese firm Themis Bioscience has been awarded PRIME designation for its candidate chikungunya fever vaccine, unlocking enhanced regulatory support from the European medicines regulator. 11 June 2018
On Friday, the European Commission granted marketing authorization for Tagrisso (osimertinib) as monotherapy for the first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. 11 June 2018
The European Commission (EC) has approved a new indication for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. 8 June 2018
At the European Medicines Agency’s (EMA) June management board meeting, members discussed progress in preparations for the agency’s relocation to Amsterdam and other matters related to Brexit, including the impact on implementation of the new EU Clinical Trials Regulation (CTR). 8 June 2018
BioMarin Pharmaceutical says it has received $20 million in milestone payments as a result of regulatory progress for its out-licensed breast cancer compound. 7 June 2018
Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1, the European Medicines Agency stated on Friday. 4 June 2018
In health care, who should decide value? In many industrialized countries with single-payer health systems, the answer is “the government.” 4 June 2018
Swiss pharma giant Roche saw its shares close up 2.32% at 215.95 euros on Friday after it announced that its combination treatment for breast cancer had received approval in Europe. 2 June 2018
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 28-31, 2018 meeting. 2 June 2018
Following a favorable opinion from the European Medicines Agency advisory committee in March this year, the European Commission (EC) has now approved the first poly ADP-ribose polymerase (PARP) inhibitor licensed for ovarian cancer in the European Union. 30 May 2018
France’s AB Science will not fight the latest negative recommendation that it has received from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for masitinib. 29 May 2018
The European Medicines Agency has accepted a filing from Japan’s Mitsubishi Tanabe Pharma to market edaravone for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease. 29 May 2018
Anglo-American law firm Hogan Lovells has issued a note explaining that Brexit has created ambiguity around the future legal status of the new EU Clinical Trials Regulation (CTR) in the UK. 24 May 2018
ViiV Healthcare and Janssen have received the nod from the European Commission (EC) for the first two-drug regimen, once-daily, single-pill for HIV. 21 May 2018
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