The US Food and Drug Administration yesterday issued a Complete Response Letter related to the New Drug Application (NDA) for stannsoporfin. 23 August 2018
The US Food and Drug Administration yesterday approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). 23 August 2018
The US Food and Drug Administration has issued a Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Esmya (ulipristal acetate; UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids. 22 August 2018
The US Food and Drug Administration (FDA) has granted priority review to Alexion's ALXN1210, a long-acting C5 complement inhibitor, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 21 August 2018
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Tagrisso (osimertinib) for the first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. 21 August 2018
The China Food and Drug Administration (CFDA) has asked the country’s second-biggest rabies vaccine maker Changchun Changsheng Biotechnology to terminate the production of its Vero-cell rabies vaccines in July 2018 for violating the country’s drug production quality protocols. 21 August 2018
Takeda's first-in-class allogneic stem cell therapy for the treatment of perianal fistulas in patients suffering from Crohn's Disease has been snubbed in a recommendation of the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 20 August 2018
The Chinese company Zhejiang Tianyu is no longer authorized to manufacture the valsartan active substance for European Union medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements, the European Medicines Agency announced today (August 20). 20 August 2018
Vertex Pharmaceuticals' Orkambi (lumacaftor/ivacaftor) is set to be reimbursed on Australia's Pharmaceutical Benefits Scheme after it was cleared by a cost-effectiveness watchdog. 20 August 2018
The China National Drug Administration (CNDA) has expedited the approval process for Roche's cancer therapy Alecensa (alectinib), an innovative therapy for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. 20 August 2018
Following a setback just a few days ago, when the US Food and Drug Administration issued a complete response letter (CRL) to a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) injection due to ongoing labeling discussions, the FDA has now come up with a positive decision. 17 August 2018
On Thursday, the US Food and Drug Administration (FDA) approved the first generic version of the EpiPen and EpiPen Jr (epinephrine) auto-injectors for the emergency treatment of allergic reactions. 17 August 2018
Despite gaining US approval for what is considered an important added indication for its cancer drug Lenvima (lenvatinib), Japanese pharma major Eisai saw its shares dip 1.7% to 9,569 yen by the time trading in Tokyo came to a halt today. 17 August 2018
Officials are facing swift action in China over a vaccine scandal that has hit stocks and risked undermining public confidence in healthcare in the country. 17 August 2018
India's largest drugmaker, Sun Pharmaceutical, closed more than 3% up on Thursday after the US Food and Drug Administration (FDA) approved its ophthalmic drug Cequa (cyclosporine ophthalmic solution). 16 August 2018
The US Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals' Kalydeco (ivacaftor) for use in cystic fibrosis patients under the age of 24 months. 16 August 2018
A week ago, the US Food and Drug Administration (FDA) held up Apotex’s submission for potassium chloride as the first application to market a copycat drug that merited being granted the regulator’s new Competitive Generic Therapy designation. 14 August 2018
Shares in rare disease specialist Amicus Therapeutics unsurprisingly closed up on Friday following the approval of its Fabry disease drug Galafold (migalastat), but it was a different story on Monday. 14 August 2018
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
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