Tumor drug resistance specialist Deciphera Pharmaceuticals has filed for US approval for oncology candidate ripretinib, a broad-spectrum KIT and PDGFRα inhibitor. 16 December 2019
There are currently no approved treatments for the increasingly prevalent liver disease non-alcoholic steatohepatitis (NASH), but this looks highly likely to change within the next year. 16 December 2019
Rare and rheumatic disease specialist Horizon Therapeutics has been boosted by a unanimous vote from a key FDA advisory panel in favor of its ophthalmic candidate teprotumumab. 16 December 2019
Ahead of the regulator's expected action date of December 28, the US Food and Drug Administration on Friday approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 milligrams per deciliter or higher. 14 December 2019
French oncology-focused biotech company Innate Pharma was down more than 5% during Friday afternoon’s trading after the firm provided an update on its TELLOMAK Phase II trial on lacutamab. 13 December 2019
Specialist HIV company ViiV Healthcare today announced it has made regulatory submissions to both the European Medicines Agency and the US Food and Drug Administration seeking approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir. 13 December 2019
Pharmaceutical leaders in the UK have responded positively to the outcome of the British general election on Friday, which returned Conservative Prime Minister Boris Johnson to power with a large majority. 13 December 2019
The US Food and Drug Administration has granted accelerated approval for its Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. 13 December 2019
The UK’s National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) have published positive appraisals recommending the use of Mulpleo (lusutrombopag) by the National Health Service (NHS) in England, Wales and Scotland for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing planned invasive procedures, Japanese drug major Shionogi. 12 December 2019
California’s Amgen and Belgian biotech UCB have won approval in Europe for Evenity (romosozumab), as an option for severe osteoporosis in postmenopausal women at high risk of fracture. 12 December 2019
Gilead Science subsidiary Kite has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 12 December 2019
Ireland-incorporated biotech Alkermes saw its shares down almost 3% at $20.93 yesterday after it received a sharp rebuke from the US regulator over advertising of its opioid dependence drug. 12 December 2019
Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in 2030. 11 December 2019
US drugmaker Vertex Pharmaceuticals has announced that the European Commission has granted a label extension for Kalydeco (ivacaftor) to allow treatment of certain cystic fibrosis (CF) patients aged from six to 12 months. 11 December 2019
A key advisory panel at the US Food and Drug Administration has recommended against approving heart med Brinavess (vernakalant hydrochloride), voting 11 against and two in favor. 11 December 2019
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. 11 December 2019
US biotech Amgen now has an approved biosimilar referencing Remicade (infliximab), the autoimmune disorders drug from the Johnson & Johnson unit Janssen. 9 December 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously-treated patients with multiple myeloma. 9 December 2019
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
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024