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
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
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
Leading Russian drugmakers, as well as global pharmaceutical producers, operating in Russia fear of the possible collapse of the local pharmaceutical market after February, 1 2021 – the date, when the simplified period of work of a drug labelling system ends, reports The Pharma Letter’s local correspondent. 5 January 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has formally launched the Innovative Licensing and Access Pathway (ILAP). 4 January 2021
An Indian government’s expert panel has reportedly recommended approval of the vaccine, developed by AstraZeneca and Oxford University for emergency use in India to provide immunity against COVID-19, according to local media reports. 4 January 2021
Zydus Cadila, a part of Cadila Healthcare, on Sunday announced that it will be starting Phase III clinical of ZyCoV-D, its plasmid DNA vaccine to prevent COVID-19, after having received permissions from the Drugs Controller General of India (DCGI). 4 January 2021
The World Health Organization (WHO) on December 31 listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine, previously dubbed BNT162b2, the first to receive emergency validation from the WHO since the outbreak began a year ago. 1 January 2021
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