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
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
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 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
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 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
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 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
As demand for the India-made COVID-19 vaccines gathers pace in foreign countries, even China seems to have grudgingly conceded that India's COVID-19 vaccines are good, reports The Pharma Letter’s local correspondent. 11 January 2021
US biotech EQRx, which is committed to developing and delivering important new medicines at lower prices, today announced that it has raised $500 million in Series B financing. 11 January 2021
Swiss pharma giant Roche has picked up European approval for Xofluza (baloxavir marboxil), a treatment for flu in people 12 years and over. 11 January 2021
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) to add overall survival (OS) and other secondary endpoint data from the Phase III ARAMIS trial to the Nubeqa (darolutamide) Prescribing Information, German pharma and crop sciences major Bayer announced late Friday. 9 January 2021
On Friday, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the approval of the Office of Generic Drugs’ (OGD) reorganization. 9 January 2021
Rick Brar, chief executive at Brains Bioceutical, considers the implications of the UK’s departure from the European Union (EU) in an Expert View piece. 8 January 2021
The COVID-19 vaccine developed by US biotech Moderna has today been given regulatory approval for emergency supply by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 8 January 2021
The HELIOS-A Phase III study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis, met its primary and both secondary endpoints at nine months in patients with hATTR amyloidosis with polyneuropathy. 8 January 2021
An increase in demand for Active Pharmaceutical Ingredients (APIs) from India is a result of increasing customer diversification away from China, with some countries adopting a 'China plus one' policy. 7 January 2021
The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Forxiga (dapagliflozin) for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults, as an add-on to optimised standard care. 7 January 2021
Women in the UK receiving treatment for epilepsy are being urged to discuss with a healthcare professional the right treatment for them if they anticipate becoming pregnant even sometime in the future, following a safety review. 7 January 2021
UK pharma major AstraZeneca has announced that its COVID-19 vaccine AZD1222 has been granted emergency-use authorization in India, as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunization of adults. 6 January 2021
The European Medicines Agency today announced its recommendation for conditional marketing authorization to be granted to another novel coronavirus vaccine. 6 January 2021
Despite dealing with the urgent need to evaluate vaccines, drugs and diagnostics tests relating to the COVID-19 pandemic, the US Food and Drug Administration cleared a bumper number of novel drugs last year. 6 January 2021
The US regulator has accepted the New Drug Application for Priority Review submitted for Farxiga (dapagliflozin), raising hopes the diabetes med could become the first SGLT2 inhibitor for people with chronic kidney disease (CKD), with and without type 2 diabetes. 6 January 2021
The US. Food and Drug Administration has accepted for priority review the New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. 6 January 2021
Specialty biopharma Marius Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of Kyzatrex, its oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in men. 5 January 2021
Japanese drugmaker Daiichi Sankyo says it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for teserpaturev (G47∆), an oncolytic virus, for the treatment of patients with malignant glioma. 5 January 2021
Swiss pharma giant Roche’s novel cancer immunotherapy tiragolumab has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration, in combination with Tecentriq (atezolizumab). 5 January 2021