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
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 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 Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 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
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
Shares of Acacia Pharma closed up 4.5% at 2.22 euros today, as the UK company revealed that the US Drug Enforcement Administration (DEA) has designated its procedural sedative Byfavo (remimazolam injection) as a Schedule IV medicine. 6 October 2020
Less than a week after the European Medicines Agency (EMA) started the first ‘rolling review’ of a COVID-19 vaccine, the regulator has begun another. 6 October 2020
South Korea’s Samsung Bioepis and Biogen today announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). 6 October 2020
In what is not an unexpected decision, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required post-market study failed to verify clinical benefit and it has been concluded that the available evidence does not show Makena is effective for its approved use. 6 October 2020
After 13 years of research, India's first personalized medicine for Duchenne muscular dystrophy (DMD) has received the green signal from the Drug Controller General of India (DCGI), paving the way for clinical trials. 5 October 2020
At the October 2020 meeting of the European Medicines Agency’s management board, the particular focus was on the Agency’s activities in response to the COVID-19 pandemic. 5 October 2020
The US Food and Drug Administration had issued a Complete Response Letter to Mesoblast's Biologics License Application (BLA) for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). 5 October 2020
The US Food and Drug Administration has approved Opdivo (nivolumab) + Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). 3 October 2020
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of a safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir). 3 October 2020
The European Commission (EC) has approved Crysvita (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphatemia (XLH), Japanese drugmaker Kyowa Kirin announced today. 2 October 2020
AstraZeneca’s Farxiga (dapagliflozin) is already a blockbuster, boasting 2019 sales of $1.47 billion based on an initial approval as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes (T2D) and to reduce the risk of hospitalization for heart failure (hHF) in patients with T2D and established cardiovascular (CV) disease or multiple CV risk factors. 2 October 2020
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for avalglucosidase alfa, for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. 2 October 2020
Solid Biosciences said yesterday that the US Food and Drug Administration has lifted the clinical hold placed on the company’s IGNITE DMD Phase I/II clinical trial. of SGT-001, a gene transfer candidate under investigation for Duchenne muscular dystrophy (DMD). 2 October 2020
The US Food and Drug Administration (FDA) has issued a final guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment, which is intended to help companies develop drugs to treat the condition and addresses the clinical endpoints acceptable for demonstrating the effectiveness of drugs for the disorder. 2 October 2020
The European Medicines Agency’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, AZD1222, which is being developed by AstraZeneca in collaboration with the University of Oxford. 1 October 2020
Speaking at the Financial Times’ US Pharma and Biotech Conference yesterday, Moderna Therapeutics’ chief executive Stéphane Bancel stated that the company will not be able to apply for emergency use authorization (EUA) in the USA for its COVID-19 vaccine candidate mRNA-1273 before November 25 at the earliest, reflecting the minimum amount of time needed to accumulate enough safety data. 1 October 2020
Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca, has announced that its biosimilar to Roche’s Avastin (bevacizumab) has been approved by the European Commission (EC). 30 September 2020
The US Food and Drug Administration has approved Alkindi Sprinkle (hydrocortisone oral granules) as replacement therapy in pediatric patients with adrenocortical insufficiency (AI) from UK specialty pharma company Diurnal. 30 September 2020
Japanese drugmaker Otsuka Pharmaceuticals has submitted an application for approval of MM36 (difamilast) to the Japanese regulatory authorities. 29 September 2020
Health Canada has approved Reblozyl (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia. 29 September 2020