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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
The Chinese National Medical Products Administration (NMPA) has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. 21 December 2019
Indian drugmaker Glenmark Pharmaceuticals says that partner Seqirus has received marketing approval for Ryaltris (olopatadine hydrochloride [665mcg] and mometasone furoate [25mcg]) from Australia’s Therapeutic Goods Administration (TGA), Australia. 20 December 2019
The Johnson & Johnson unit Janssen has announced that the European Commission (EC) has approved an indication for Spravato (esketamine), the first antidepressant medicine with a new mechanism of action in more than 30 years. 20 December 2019
East Coast, USA-based cancer specialist Epizyme has scored a unanimous vote in favor of its candidate tazemetostat, from the US regulator's cancer advisory panel. 19 December 2019
The European Commission (EC) has approved Kadcyla (trastuzumab emtansine) for the adjuvant treatment of adults with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy. 19 December 2019
Seattle Genetics and development partner Astellas have been awarded accelerated approval in the USA for Padcev (enfortumab vedotin-ejfv), for certain people with bladder cancer. 19 December 2019
The US Food and Drug Administration has accepted US pharm giant Pfizer’s supplemental New Drug Application (sNDA) for Braftovi (encorafenib), in combination with Erbitux (cetuximab; Braftovi Doublet) based on the results from the Phase III BEACON CRC trial. 19 December 2019
European Commission has granted approval for Rinvoq (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). 19 December 2019
The US Food and Drug Administration’s (FDA) Janet Woodcock has delivered a statement on the impact of the agency’s proposals on bringing low-cost biosimilar and interchangeable protein products to market. 18 December 2019
Keytruda (pembrolizumab) looks set to become the first in its class to win approval for a hard-to-treat kind of bladder cancer, following a positive vote from the US regulator’s cancer advisory panel. 18 December 2019
Organized by Informa Markets, CPhi & P-MEC India 2019 recently closed its doors to over 45,000 visitors and 1,600+ exhibitors from 44 countries, making it the largest pharmaceutical trade show in South Asia. 18 December 2019
The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) voted by a narrow margin of 7 to 5 in favor of recommending Lynparza (olaparib) as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas, whose disease has not progressed following 1st-line platinum-based chemotherapy 18 December 2019
A report from the European Medicines Agency (EMA) on pharmacovigilance activities finds that the EU system is: “strong and adaptable,” creating: “a positive impact on public health.” 17 December 2019
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) in metastatic castration-sensitive prostate cancer (mCSPC). 17 December 2019
On Monday, stock in New York, USA-based Axsome Therapeutics finished the day around 70% higher, after the firm announced positive late-stage data for AXS-05, a novel NMDA receptor antagonist. 17 December 2019
Christian Hebenstreit, general manager and senior vice president of Medidata EMEA, a technology company that develops and markets software as a service for clinical trials, has provided his view on issues, challenges and trends for the life sciences industry as we head into 2020. 17 December 2019