The US Food and Drug Administration’s recent approval of Aduhelm (aducanumab) to treat patients with Alzheimer's disease using the accelerated approval pathway has been questioned and now this is to be investigated by the Office of the Inspector General at the Department of Health and Human Services. 5 August 2021
The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, in March to select the influenza viruses for the composition of the influenza vaccine for the 2021-2022 US influenza season. 5 August 2021
Patients in the USA with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy will no longer be given Istodax (romidepsin). 4 August 2021
Swiss drugmaker Novartis has announced that the US Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) trials for spinal muscular atrophy (SMA) patients can go ahead. 3 August 2021
USA-based cell and gene therapy specialist Mustang Biotech’s shares edged up 1.4% to $2.83 in after-hours trading, following the0 announcement that the European Medicines Agency has granted Priority Medicines (PRIME) designation to MB-107, its lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID) in newly diagnosed infants, also known as bubble boy disease. 3 August 2021
Anglo-Swedish pharma major AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the USA for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. 2 August 2021
Japanese pharma major Eisai closed up 1.2% at 9,092 yen today, as it announced that its anti-epileptic drug (AED) Fycompa (perampanel) has obtained two additional approvals in China. 2 August 2021
Indian pharmaceutical companies are set to gain from the US Food and Drug Administration's changed stance on biosimilar versions of biological medicines. With the US FDA approving a biosimilar interchangeable insulin product for the treatment of diabetes for the first time in the country, the doors appear to have been opened for generic players, with many considering it a shot in the arm, reports The Pharma Letter’s India correspondent. 2 August 2021
The European Medicines Agency’s human medicines committee (CHMP) has approved a scale-up of the active substance production process at US mRNA-based biotech Moderna's COVID-19 vaccine manufacturing sites in the USA. 2 August 2021
Shares in Californian kidney specialist Ardelyx are up a quarter in pre-market trading, despite the firm receiving a Complete Response Letter (CRL) for its candidate tenapanor. 30 July 2021
The US Food and Drug Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). 30 July 2021
Johnson & Johnson’s partner for manufacturing its coronavirus vaccine, Emergent BioSolutions, has announced it will be able to resume operations at its plant in Bayview, USA. 30 July 2021
US biotech Arrowhead Pharmaceuticals today announced that it was granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration for ARO-AAT, also known as TAK-999, the company’s second-generation investigational RNA interference (RNAi) therapeutic. 29 July 2021
Japan’s largest drugmaker Takeda Pharmaceutical says that the US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to TAK-994, its Phase II investiga00tional oral orexin agonist, which is designed to selectively target orexin 2 receptors. 29 July 2021
The US Food and Drug Administration has revised the Emergency Use Authorization (EUA) for baricitinib, sold under the brand name Olumiant by Eli Lilly’s), now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients. 29 July 2021
The US Food and Drug Administration has accepted Roche’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the Swiss pharma giant’s submission for diabetic retinopathy. 29 July 2021
The US Food and Drug Administration today alerted patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. 28 July 2021
Chicago, USA-based antimicrobial resistance specialist Iterum Therapeutics announced a regulatory setback for its candidate, oral sulopenem, on Monday. 27 July 2021
At the Alzheimer’s Association International Conference (AAIC), taking place in Colorado, USA, newly-approved Aduhelm (aducanumab) is understandably the main focus of attention. 27 July 2021
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
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024