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
North Carolina, USA-based rare disease specialist BioCryst Pharmaceuticals has announced results from its Phase III APeX-2 trial of the investigational hereditary angioedema (HAE) therapy BCX7353. 22 May 2019
The US Supreme Court on Monday ruled that a lower court should consider dismissing the claims of more than 500 patients who blame pharma giant Merck & Co for not warning them about the risks of femoral fractures related to the company’s drug Fosamax (alendronate). 21 May 2019
Belgian biopharma UCB started the week by announcing that the US Food and Drug Administration (FDA) approval of Nayzilam (midazolam) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy. 20 May 2019
A draft issued on March 29 by China’s National Health Commission (CNHC), which regulates hospitals in China, allows qualified 3 Jia ( meaning top-level) public hospitals to develop and commercialize somatic cell therapies within their own hospitals. 17 May 2019
The European Medicines Agency’s safety committee has called for the withdrawal of medicines containing fenspiride and temporary restrictions on the use of Xeljanz (tofacitinib) at its monthly meeting over May 13-16. 17 May 2019
The US Food and Drug Administration (FDA) wants to hear feedback on its product-specific guidances aimed at stimulating generic drug development. 17 May 2019
The US Food and Drug Administration said on Thursday it has approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. 17 May 2019
The Roche and AbbVie partnered asset Venclexta (venetoclax) has won US approval in combination with Gazyva (obinutuzumab) as a first-line, chemo-free option in chronic lymphocytic leukemia (CLL). 16 May 2019
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted in favor of approving one cancer drug from Japanese drugmaker Daiichi Sankyo but voted against another one. 15 May 2019
The US Food and Drug Administration (FDA) has approved Bavencio (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC; kidney cancer). 15 May 2019
Industry group the Alliance for Safe Biologic Medicines (ASBM) claims there is “overwhelming support” for the US Food and Drug Administration’s new suffix-based naming system for biologic medicines and biosimilars. 14 May 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma. 14 May 2019
On May 10, 2019, the US Food and Drug Administration approved Cyramza (ramucirumab) from US pharma major Eli Lilly as a single agent for hepatocellular carcinoma (HCC; liver cancer) in patients who have an alpha fetoprotein (AFP) of ≥ 400ng/mL and have been previously treated with sorafenib (Nexavar). 13 May 2019
Ned Sharpless, Acting Commissioner of the US Food and Drug Administration, has issued a statement outlining final guidance aimed at helping bring interchangeable biosimilars to market. 13 May 2019
The US Food and Drug Administration (FDA) has released final guidance on the basis for generic drugmakers to determine whether to submit an Abbreviated New Drug Application (ANDA) or 505(b)(2) application for products. 13 May 2019
The Dutch Medicines Evaluation Board (MEB) will no longer publish the full product information about the active substance of generic medicinal products on its website if an indication is still subject to a patent. 13 May 2019
While Waylivra (volanesorsen) has been snubbed by the US Food and Drug Administration, Europe’s regulator saw enough hopeful data to give the therapy a conditional approval in familial chylomicronemia syndrome (FCS). 10 May 2019
US-based Sunovion Pharmaceuticals and PsychoGenics have been granted Breakthrough Therapy designation for SEP-363856, a novel agent for the treatment of people with schizophrenia. 10 May 2019