The US Food and Drug Administration (FDA) has approved Slayback Pharma’s abbreviated new drug application (ANDA) for a generic equivalent of the Makena injection (hydroxyprogesterone caproate) 1,250mg/ 5mL multi-dose vial. 2 January 2019
Heron Therapeutics’ shares were up 5.85% at $25.14 by late morning on Monday, after the company announced an important development for its drug candidate HTX-011. 1 January 2019
Endo International today announced that, due to the ongoing federal government shutdown, the US Food and Drug Administration has requested a further stay of Endo's ongoing litigation against the FDA for the duration of the shutdown. 31 December 2018
Patients with an advanced form of lung cancer will receive early access to Roche’s immunotherapy treatment Tecentriq (atezolizumab) in combination with chemotherapy and the Swiss company’s older oncology drug, Avastin (bevacizumab). 31 December 2018
Chinese regulator the National Medical Products Administration (NMPA) has approved Tyvyt (sintilimab) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL). 28 December 2018
The New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration. 27 December 2018
Braeburn Pharmaceutical announced on Sunday that the US Food and Drug Administration has granted tentative approval of Brixadi (buprenorphine; CAM2038) extended-release weekly injections. 24 December 2018
Russia’s pharmaceutical industry professional associations last week called for maintaining the technical conditions for implementing the project for monitoring the movement of medicines within the framework of the requirements developed earlier in the pilot project. 24 December 2018
Acorda Therapeutics’ Inbrija (levodopa inhalation powder) on Friday became the first Food and Drug Administration-approved inhaled levodopa for the intermittent treatment of OFF episodes in people with Parkinson’s disease. 24 December 2018
US biotech Stemline Therapeutics has been granted US Food and Drug Administration approval of Elzonris (tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. 22 December 2018
The US Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. 21 December 2018
China, with its reformed priority review and approval processes, is supporting biotech revolution in the country and thereby allowing domestic drug developers to compete with well-established multinational counterparts. 21 December 2018
Tokyo-based Chugai Pharmaceutical has won Japanese approval for additional dosing options for Hemlibra (emicizumab), a coagulation factor VIII substitute. 21 December 2018
Following a review of fluoroquinolone antibiotics, the US Food and Drug Administration has issued a statement regarding an association with a rare but serious side effect. 21 December 2018
Predicting a year in pharma is difficult at the best of times, but in an era of enormous uncertainty – with politics in established markets as impulsive as it is divisive – it's hard to know what drugmakers will have to deal with in 2019, and how their strategies will play out. 20 December 2018
French biopharma company DBV Technologies announced after market close on Wednesday that, after discussions with the US Food and Drug Administration, its Biologics License Application (BLA 20 December 2018
The US Food and Drug Administration has granted Breakthrough Therapy Designation for the anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD). 20 December 2018
Following the October recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to approve use of the dengue vaccine in European endemic areas, the European Commission has now granted marketing authorization for Dengvaxia (dengue tetravalent vaccine [live, attenuated]). 20 December 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
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