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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
Californian cardiorenal specialist Ardelyx has won US approval for Ibsrela (tenapanor), an oral treatment for irritable bowel syndrome with constipation (IBS-C) in adults. 13 September 2019
The US Food and Drug Administration has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma. 13 September 2019
With the aim of curbing diversion and misuse, the US Drug Enforcement Administration (DEA) is proposing to reduce the amount of five Schedule II opioid controlled substances that can be manufactured in the United States next year compared with 2019, per the Notice of Proposed Rulemaking being published in the Federal Register and available for public inspection here. 12 September 2019
Two months after the start of the first stage of labeling (labeling of drugs for high cost nosology), the Russian government approved a new cryptocode length. 11 September 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation for the investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy. 11 September 2019
Approval for an easy-to-use glucagon formulation from Xeris Pharmaceuticals is set to give Eli Lilly’s Baqsimi (glucagon) a run for its money in the USA. 11 September 2019
As incoming European Commission President Ursula von der Leyen prepares to take office at the end of next month, representatives from the pharmaceutical industry are stepping up lobbying efforts on behalf of the sector. 10 September 2019
A highly-anticipated report from Public Health England (PHE) finds that up to a quarter of adults are being prescribed medication for pain, insomnia or depression. 10 September 2019
Ireland-incorporated Horizon Therapeutics has announced that the US Food and Drug Administration has accepted the Biologics License Application (BLA) for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation. 10 September 2019
Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer. 9 September 2019
The US Food and Drug Administration on Friday approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. 7 September 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC). 6 September 2019
Switzerland’s Roche has secured European approval for Tecentriq (atezolizumab), in combination with chemotherapy, for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). 6 September 2019
European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. 6 September 2019
The European medicines regulator has approved Lonsurf (trifluridine/tipiracil) for adults with metastatic gastric cancer, as a later-line option. 6 September 2019
Japan’s largest drugmaker Takeda Pharmaceutical is issuing a US recall for all doses of Natpara (parathyroid hormone) for Injection (25mcg, 50mcg, 75mcg, and 100mcg), 6 September 2019
Cancer drugs currently account for 27% of all new drug approvals in the USA since 2010, a dramatic increase from the 4% share of the 1980s, according to a newly-completed analysis. 6 September 2019
Shares of US biotech firm Magenta Therapeutics edged up more than 2% to $9.97, after it announced that the US Food and Drug Administration granted Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders. 5 September 2019
More than $1.8 billion has been released by the US Department of Health and Human Services (HHS) to help combat the opioid crisis in the USA. 5 September 2019
A novel gene therapy treatment for a rare inherited eye disorder has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for use on the National Health Service (NHS). 5 September 2019