Danish biotech firm Genmab and Swiss firm Seagen have filed a Biologics License Application with the US Food and Drug Administration for accelerated approval for their tisotumab vedotin. 11 February 2021
AbbVie has picked up a twelfth indication for Botox (onabotulinumtoxinA), opening a new revenue stream in the therapeutic and cosmetic workhorse’s sunset years. 10 February 2021
Fresenius Kabi Oncology Limited (FKOL), the Indian unit of Germany-headquartered Fresenius Kabi, has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration plant inspection and pay $50 million in fines and forfeiture, the Department of Justice announced yesterday. 10 February 2021
The U S Food and Drug Administration has granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700mg and etesevimab (LY-CoV016) 1,400mg together. 10 February 2021
The US Food and Drug Administration has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. 10 February 2021
A key scientific panel of the US medicines regulator has voted unanimously to wait for more data before deciding on a bid to broaden the label for Keytruda (pembrolizumab). 10 February 2021
Bristol Myers Squibb has won approval in Europe for Inrebic (fedratinib), to treat enlarged spleen in certain people with myelofibrosis, a rare bone marrow disorder. 9 February 2021
European approval has been granted to Viiv Healthcare for Rukobia (fostemsavir) 600mg extended-release tablets, for use alongside other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 8 February 2021
The European Commission (EC) has authorized the expanded use of Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder (MDD). 8 February 2021
On Friday, the US Food and Drug Administration granted accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon. 8 February 2021
The US Food and Drug Administration on Friday at last approved Breyanzi (lisocabtagene maraleucel – liso-cel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. 8 February 2021
Janssen Biotech has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. 5 February 2021
The US Food and Drug Administration is again alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. 5 February 2021
The China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test. 4 February 2021
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF). 4 February 2021
The US Food and Drug Administration late yesterday granted accelerated approval to Tepmetko (tepotinib), from EMD Serono, the US healthcare business of Germany’s Merck KGaA for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. 4 February 2021
Californian biopharma Durect Corporation has announced that the US Food and Drug Administration (FDA) has approved Posimir (bupivacaine solution). 3 February 2021
Xarelto (rivaroxaban) has been approved in the UK to treat venous thromboembolism (VTE) and to prevent VTE recurrence in children from birth to below 18 years after at least five days of initial parenteral anticoagulation treatment, including catheter related thrombosis, cerebral vein and sinus thrombosis. 1 February 2021
The European Commission has granted marketing authorization for Trimbow (beclomethasone/formoterol/glycopyrronium), an extrafine formulation triple fixed combination therapy in a single inhaler, as a maintenance treatment for adult asthma patients. 1 February 2021
Last week saw the UK’s AstraZeneca tell the European Commission that, due to glitches at its production facilities in Europe, it would be unable fully meet its supply commitment on its COVID-19 vaccine (AZD1222), which at that point had not been cleared for use by the European Medicines Agency. 30 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