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
The US Food and Drug Administration on Monday approved the investigational two-drug single-tablet regimen (STR) Dovato (dolutegravir/lamivudine) for the treatment for HIV-1 infection in adults who have not previously been treated with antiretroviral drugs. 9 April 2019
Japanese pharma major Eisai says that its in-house discovered fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor E7090 has been granted the Sakigake designation by Japan’s Ministry of Health, Labor and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion. 8 April 2019
US biotech major Celgene and Acceleron Pharma today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, 8 April 2019
The European Medicines Agency has granted a PRIME (PRIority MEdicines) designation for the investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-68284528 (JNJ-4528). 5 April 2019
Bristol-Myers Squibb has secured a positive reimbursement decision for its Opdivo (nivolumab) plus Yervoy (ipilimumab) combination, for use against kidney cancer, in the UK. 5 April 2019
Three pharmaceutical companies have agreed to pay $122 million to settle US Department of Justice (DoJ) allegations that kickbacks were paid to promote uptake of their products. 5 April 2019
Investors in USA-based AVEO Oncology appear to be fearing the worst after the future of the company’s lead candidate was thrown into doubt. 4 April 2019
USA-based Evoke Pharma says it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its 505(b)(2) New Drug Application (NDA) for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. 3 April 2019
The immediate response of the pharmaceutical industry to the resignation of US Food and Drug Administration Commissioner Dr Scott Gottlieb on March 5, 2019, was one of shock. 3 April 2019
China’s state council last August announced reform goals, which included speeding up the approval process for imported drugs, and seeking to include more oncology drugs in the national reimbursement drug list. 2 April 2019
More and more global drugmakers operating in Russia are considering suspension sales of at least part of their new range in the local market in the coming years, due to new rules on price regulation that were recently approved by the Russian Ministry of Health and which will take effect in 2020, according to recent statements of producers. 2 April 2019
The European Commission has granted the Marketing Authorization for Ajovy (fremanezumab) 225mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. 1 April 2019
The European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for subcutaneous (SC) Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). 1 April 2019
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submission for cefiderocol from Shionogi. 1 April 2019