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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
The research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Shares of US drugmaker Vertex Pharmaceuticals closed down 2.6% at $323.30 yesterday, despite the firm announcing that the US Food and Drug Administration (FDA) has approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor). 27 April 2023
The US Food and |Drug Administration (FDA) has released briefing documents for the April 28, 2023, Advisory Committee Meeting (AdCom) discussing the supplemental new drug application (sNDA) for UK AstraZeneca’s Lynparza (olaparib) in first-line (1L) metastatic castration-resistant prostate cancer (mCRPC). 27 April 2023
The International Council for Harmonization (ICH) has initiated the process for a new guideline on bioequivalence requirements for the approval of medicines, which is an important milestone for global convergence. 26 April 2023
The US Food and Drug Administration (FDA) yesterday approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). 26 April 2023
Kidney disease specialist Akebia Therapeutics saw its shares lifted over 6% on Monday, following a European approval for Vafseo (vadadustat). 26 April 2023
Foghorn Therapeutics’ shares slid as much as 21% in pre-market activity on Monday, and closed down 7.9% at $6.19, after the US cancer-focused biotech announced a setback on the FHD-609 program in synovial sarcoma and SMARCB1-deleted tumors. 25 April 2023
The European Medicines Agency has provided Johnson & Johnson with its first regulatory approval for Akeega (niraparib/abiraterone acetate). 24 April 2023
French gene therapy company GenSight Biologics saw its shares crash 69% by close of trading on Friday, and fall a further 10.3% to 0.66 euros in early trading today, after it announced the withdrawal of its European regulatory filing for what could be the first gene therapy for Leber hereditary optic neuropathy (LHON) patients. 24 April 2023
US retinal disease specialist Apellis Pharmaceuticals has announced post hoc analyses from the 24-month, Phase III OAKS and DERBY studies evaluating Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 24 April 2023
Shares of French biotech Maat Pharma (Euronext Paris: MAAT) edged up more thatn 2% to 9.70 euros this morning, after it revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold and cleared it Phase III Investigational New Drug (IND) application for lead microbiome ecosystem therapy (MET) candidate, MaaT013, in patients with acute Graft-versus-Host Disease (aGvHD). 24 April 2023
The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials submitted as pivotal evidence in support of marketing authorization applications. 21 April 2023
The European Commission has granted a marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 21 April 2023
Following a positive advisory committee meeting last month, the US Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq). 20 April 2023
US biopharma SAB Biotherapeutics has received both Breakthrough and Fast Track designations for SAB-176 from the US Food and Drug Administration (FDA) in the past week. 20 April 2023
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for Lonsurf (trifluridine/tipiracil), Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings, have revealed. 19 April 2023
While the US regulator’s scientists have given a positive opinion for Innoviva’s (Nasdaq: INVA) new antibiotic, the details appear not to have impressed investors, with shares falling 5% on Tuesday. 19 April 2023
Chicago-USA-based drugmaker AbbVie has announced that the US Food and Drug Administration (FDA) has approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. 18 April 2023