The US Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. 19 December 2016
Merck & Co has received approval in Japan for its immuno-oncology drug Keytruda (pembrolizumab) to treat certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first and second-line treatment settings. 19 December 2016
The European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. 19 December 2016
Bangladeshi generic drugs company Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a generic equivalent of Glucophage XR tablets (metformin hydrochloride). 19 December 2016
Based on a US Food and Drug Administration review of a large clinical trial that FDA required the drug companies to conduct, the agency has determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. 19 December 2016
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. 19 December 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
Agios Pharmaceuticals saw its shares drop 20% to $44.74 today, after it announced that development of its second pyruvate kinase-R (PKR) activator, AG-519, was to be discontinued. 16 December 2016
The publication of a second draft recommendation not recommending use of Takeda’s Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma (R/R HL) on the National Health Service (NHS), has prompted fresh criticism from the Japanese drugmaker. 16 December 2016
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Japanese drugmaker Takeda’s Adcetris (brentuximab vedotin) to treat some patients with Hodgkin’s lymphoma on the National Health Service (NHS). 15 December 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC consulted on a proposal to list ranibizumab (Lucentis) and aflibercept (Eylea) in Section H of the Pharmaceutical Schedule from November 1, 2016 for the second and third line treatment (respectively) of wet age-related macular degeneration (wAMD). 15 December 2016
GlaxoSmithKline has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy. 15 December 2016
USA-based Intercept Pharmaceuticals has won conditional marketing authorization from the European Commission for its liver disease drug Ocaliva (obeticholic acid). 14 December 2016
Swissmedic has published amendments to regulations for drug manufacturers when highlighting changes to manuscripts of medicinal product information relating to their products. 14 December 2016
The European Commission has granted marketing authorization for Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October. 14 December 2016
The UK regulator has ruled on breaches of the Association of British Pharmaceutical Industry code of conduct by five separate pharma companies. 13 December 2016
The Russian Federal Antimonopoly Service (FAS) has designed a mechanism for the withdrawal of licenses on the production of drugs in Russia from their rightful owners, according to Igor Artemyev, head of the FAS. 13 December 2016
The US Food and Drug Administration has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. 13 December 2016
As a result of an updated review, the US Food and Drug Administration has concluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. 13 December 2016
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
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