Finnish drugmaker Orion Corp and Germany’s Bayer have filed a marketing authorization applications with the European Medicines Agency for their jointly-developed darolutamide for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC). 8 March 2019
Today, US biopharma major AbbVie announced that the US Food and Drug Administration has granted a Breakthrough Therapy designation (BTD) to venetoclax (marketed as Venclexta) for use in combination with obinutuzumab as a fixed duration, first-line chemotherapy-free combination for patients with chronic lymphocytic leukemia (CLL) who have not been previously treated. 7 March 2019
In January of this year, the US Food and Drug Administration released updated draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” This replaces the previous version issued in 2015.1 7 March 2019
German pharma and crop sciences major Bayer has submitted an application for marketing authorization to Japan’s Ministry of Health, Labor and Welfare (MHLW) for darolutamide for the treatment of patients with castration-resistant prostate cancer (CRPC). 6 March 2019
The US Food and Drug Administration yesterday approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). 6 March 2019
The US Food and Drug Administration has accepted the New Drug Application (NDA) for fedratinib and granted a Priority Review to the filing. 6 March 2019
Senators in the US Congress have written to the US Food and Drug Administration seeking changes to official guidance, with the aim of expediting the release of new biosimilar insulin products. 5 March 2019
A New Jersey, USA-based addiction treatment center has warned that the US regulator’s expected approval of ketamine to address depression could cause “an explosion in addiction.” 5 March 2019
The UK Medicines and Health products Agency (MHRA) has directed pharmaceutical companies and clinical trial sponsors to follow new guidelines for regulatory submissions that would have to be directly submitted to the MHRA if Britain leaves the EU without reaching an agreement by the end of this month. 5 March 2019
Even as more blood pressure drugs are being recalled in the USA after being found to contain trace amounts of a potentially cancer-causing ingredient, India’s drug controller is putting stringent quality control measures in place aiming to boost public confidence in generic medicines, reports The Pharma Letter’s India correspondent. 5 March 2019
The leading trade group for the Hungarian pharmaceutical industry has called on Hungary’s government to help prevent a decline in novel research taking place in the country. 4 March 2019
The US Food and Drug Administration determined that there is no clinical need to compound vasopressin under Section 503B of the Drug Quality and Security Act. 4 March 2019
At its last meeting in London before moving to new headquarters in Amsterdam as a result of Brexit, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made positive recommendations for the approval of seven novel medicines. 1 March 2019
The US Food and Drug Administration has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer, 1 March 2019
The China National Medical Products Association (NMPA) has approved Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA). 28 February 2019
The US Centers for Disease Control and Prevention (CDC) has issued a statement warning that the decline in annual HIV infections in the USA has stopped, with the number of new infections in the country stabilizing in recent years. 28 February 2019
British drugmaker AstraZeneca has successfully expanded the labels for Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin/metformin) to cover a new population of people with with type 2 diabetes (T2D) and moderate kidney impairment. 28 February 2019
Japanese drug major Astellas Pharma says its marketing authorization application (MAA) for the oral once-daily therapy Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) has been accepted by the European Medicines Agency for regulatory review. 28 February 2019
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 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
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