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
US drugmaker Karyopharm Therapeutics saw its shares soar nearly 30% in pre-market trading on Friday, despite revealing that the US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. 16 March 2019
The European Medicines agency has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body. The review will examine existing screening methods and their value in identifying patients at increased risk of severe side effects. 15 March 2019
A new procedure for the suspension of the use and sales of drugs in the Russian market has been developed by the Russian Ministry of Health, which used the existing federal law “On the Circulation of Medicinal Products in Russia” during its design, according to an official spokesman of the Ministry, reports The Pharma Letter’s local correspondent. 15 March 2019
The outgoing US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has called on other players in the drug development ecosystem to play their part in the modernization of clinical trials. 15 March 2019
The European Medicines Agency has granted approval for Roche to market MabThera (rituximab) against a rare condition, pemphigus vulgaris (PV). 15 March 2019
New Jersey, USA-based Merck & Co has picked up another approval in Europe for Keytruda (pembrolizumab), in combination with chemo, for the first-line treatment of squamous non-small cell lung cancer (NSCLC). 14 March 2019
In combination with chemotherapy, Tecentriq (atezolizumab) can now be used by UK patients with unresectable locally advanced or metastatic triple negative breast cancer whose tumours have PD-L1 expression of at least 1%. 14 March 2019
Roche’s Hemlibra (emicizumab) has been approved for the prevention of bleeding episodes in people with severe hemophilia A without factor VIII inhibitors in the European Union (EU). 14 March 2019
Researchers have warned that counterfeit and substandard medicines are associated with tens of thousands of deaths, with young children in poorer countries being particularly affected. 13 March 2019
Following the unexpected resignation of incumbent Dr Scott Gottlieb earlier this month, the Trump administration on Tuesday announced that National Cancer Institute (NCI) Director Norman (Ned) Sharpless will serve as acting Commissioner of the US Food and Drug Administration. 13 March 2019
More positive Phase III data for Eli Lilly’s Cyramza (ramucirumab) will support a mid-2019 regulatory push into non-small cell lung cancer (NSCLC). 13 March 2019
The US Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. 12 March 2019
The US Food and Drug Administration has approved another indication for Dupixent (dupilumab), this time for adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 12 March 2019
Johnson & Johnson has won a positive reimbursement decision in the UK with regards to the triple combo therapy Darzalex (daratumumab) plus Velcade (bortezomib) and dexamethasone, a corticosteroid medication. 12 March 2019
Following swiftly on a Japanese filing, now the US Food and Drug Administration has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. 11 March 2019
Hoping to bounce back from a bad news week, Allergan has announced the US medicines regulator will review its application for its novel CGRP agonist ubrogepant. 11 March 2019
In a move that is not totally surprising, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave a mixed reaction following its review of Sanofi’s dengue fever vaccine. 11 March 2019
In a blog post, US industry lobbyist the Pharmaceutical Research and Manufacturers of America (PhRMA) has drawn attention to a recent analysis which compares the impact of the switch from Average Wholesale Price (AWP) for Part B medicines to the Average Sales Price (ASP) system. 8 March 2019
Sanofi has been granted Priority Review from the US Food and Drug Administration for its application to extend the label for Dupixent (dupilumab). 8 March 2019