The US Food and Drug Administration has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar rituximab. 3 May 2018
The US Food and Drug Administration has granted a Rare Pediatric Disease designation to the company’s gene therapy candidate OTL-200, for the treatment of patients with metachromatic leukodystrophy (MLD). 3 May 2018
The US approval of Kymriah (tisagenlecleucel) last year enabled the Swiss pharma giant Novartis to boast that it had won the race to market with a CAR T-cell-directed therapy. 2 May 2018
Opdivo (nivolumab) has been registered by Australia’s Therapeutic Goods Administration (TGA) as an adjuvant treatment for patients with completely resected melanoma with involvement of lymph nodes or metastatic disease. 1 May 2018
On Monday, the European Commission proposed to ban two new psychoactive substances (NPS) - cycloproplyfentanyl and methoxyacetylfentanyl - across the European Union. 1 May 2018
Data from Phase II and Phase I studies was enough for the US Food and Drug Administration (FDA) to accept for priority review the Biologics License Application (BLA) for cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC patients who are not candidates for surgery. 30 April 2018
Central nervous system (CNS) specialist Lundbeck has announced a decision from the Japanese Ministry of Health, Labor and Welfare granting the Danish firm a further two years of market exclusivity on its antidepressant Lexapro (escitalopram oxalate). 27 April 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting. 27 April 2018
Washington, USA-based Omeros has been granted breakthrough therapy designation for its candidate OMS721, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients. 27 April 2018
The executive branch of the European Union has issued a set of recommendations calling for more cooperation in Europe to combat preventable diseases. 27 April 2018
A new five-year plan from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicines regulator, sets out the group's aim to “ensure a smooth EU exit under any scenario.” 26 April 2018
The US Food and Drug Administration has put a partial hold on Epizyme’s lead oncology candidate tazemetostat, after a patient in a Phase I pediatric study was found to have developed a secondary lymphoma. 26 April 2018
The US Food and Drug Administration has approved Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 26 April 2018
AbbVie has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis. 25 April 2018
In a statement to the US Senate appropriations committee, Food and Drug Administration Commissioner Scott Gottlieb reiterated his goal of “modernizing generic drug development and review,” with the aim of boosting competition in the sector and increasing rates of generic substitution, ultimately in order to lower drug costs. 25 April 2018
Japanese drug major Astellas Pharma today announced that, on March 23, it submitted a New Drug Application (NDA) for marketing approval of gilteritinib in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML). 24 April 2018
The advisory panel of the US Food and Drug Administration has delivered a mixed verdict on Eli Lilly and Incyte’s experimental rheumatoid arthritis therapy baricitinib, backing the use of the drug at a lower dose, while raising safety concerns over its use at higher dosage levels. 24 April 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