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Biotechnology
Citius Pharmaceuticals has won US Food and Drug Administration (FDA) approval for Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 9 August 2024
Pharmaceutical
In a significant move aimed at expediting access to life-saving medications for Indian patients, the Indian government has waived the requirement for conducting local clinical trials for drugs that have already received approval from regulatory authorities in the USA, UK, Japan, Australia, Canada, or the European Union. 9 August 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Crexont (carbidopa and levodopa; formerly IPX2023) extended-release capsules for the treatment of Parkinson’s disease (PD), from US drugmaker Amneal Pharmaceuticals. 9 August 2024
Biotechnology
Takeda announced that the European Commission (EC) has approved Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP). 8 August 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval for Novartis’ Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. 8 August 2024
Generics
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
Pharmaceutical
The US Food and Drug Administration approved French privately-held drug major Servier’s vorasidenib, now trade named Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for certain types of brain tumors. 7 August 2024
Biotechnology
The US subsidiary of Swiss family-owned protein specialist Octapharma today revealed that the US Food and Drug Administration (FDA) has expanded the approval of fibryga, fibrinogen (human) lyophilized powder for reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). 6 August 2024
Pharmaceutical
Shanghai-based Antengene (SEHK: 6996) has announced that the Malaysian medicines regulator has approved Xpovio (selinexor) for the treatment of multiple myeloma. 6 August 2024
Biotechnology
Actinium Pharmaceuticals’ shares closed down 60% yesterday and fell a further 10% to $2.23 in after-hours trading, when the company announced a regulatory setback for its Iead candidate. 6 August 2024
Biosimilars
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
Pharmaceutical
In common with many European countries, there are concerns in Switzerland that patients' access to some vital medicines is getting worse and worse. 5 August 2024
Biotechnology
Brussels-based UCB (OTCMKTS: UCBJF) has announced that it has received marketing authorization from the European Commission for two new 320 mg device presentations of Bimzelx (bimekizumab). 5 August 2024
Pharmaceutical
US rare disease drug focussed company Zevra Therapeutics saw its shares rise nearly 43% to $9.00 in after-hours trading on Friday as it announced a positive development for its arimoclomol. 5 August 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) has issued a reminder to businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines. 5 August 2024
Pharmaceutical
Chugai Pharmaceutical says its Taiwan subsidiary (CPT) has obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Alecensa (alectinib) 2 August 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Jemperli (dostarlimab-gxly), from UK pharm major GSK. 2 August 2024
Biotechnology
Adaptimmune Therapeutics (Nasdaq: ADAP) has received Accelerated Approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel). 2 August 2024
Biotechnology
WuXi Biologics (2269.HK), a major Chinese contract research, development, and manufacturing organization (CDMO), has had four facilities certified by the European Medicines Agency. 1 August 2024
Biosimilars
Chinese biotech Bio-Thera Solutions (SHSE: 688177) has picked up European Medicines Agency approval for BAT1706, a biosimilar referencing Avastin (bevacizumab). 1 August 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday approved the medicine Filspari (sparsentan) from Vifor France to treat primary immunoglobulin A nephropathy (IgAN). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Novavax’s Nuvaxovid jab targeting the latest subvariant. 15 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Biotechnology
Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024
Biosimilars
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
Pharmaceutical
Danish dermatology specialist LEO Pharma today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo (delgocitinib) cream. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Biotechnology
Shares of US genetic meds company MeiraGTx Holdings were up 7% at $7.12 in early trading after it announced important developments along with its third-quarter 2024 financials, reporting a $0.54 per share loss. 13 November 2024
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