Regulation
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Pharmaceutical
The US Food and Drug Administration (FDA) announced it has approved Millicent’s Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. 24 July 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved a new indication for Wegovy (semaglutide) to reduce the risk of overweight and obese adults suffering serious heart problems or strokes. 23 July 2024
Biosimilars
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
Generics
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday approved the first generic raltegravir medicines to treat adult and pediatric HIV patients 20 July 2024
Biosimilars
Gedeon Richter today announced that the European Medicines Agency (EMA) has accepted the company’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab. 19 July 2024
Pharmaceutical
Ono Pharmaceuticalannounced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib. 19 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10 mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD). 18 July 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday announced it has approved two new medicines for use in Great Britain. 18 July 2024
Pharmaceutical
Lexicon Pharmaceuticals announced that the US Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista (sotagliflozin) 17 July 2024
Pharmaceutical
Swedish drugmaker Orexo (STO:ORX) has been struck by an unexpected delay in its bid to register a high-dose naloxone rescue medication in the USA. 17 July 2024
Pharmaceutical
The wait for Eli Lilly's Mounjaro (tirzepatide) has got longer in India. 15 July 2024
Pharmaceutical
Spanish drugmaker PharmaMar has received a notification from the European Commission (EC) advising that it is revoking the refusal to grant a Marketing Authorization (MA) for Aplidin (plitidepsin) in multiple myeloma. 15 July 2024
Biotechnology
AbbVie on Friday revealed it has submitted applications for a new indication to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib) 15mg, once daily for the treatment of adult patients with giant cell arteritis (GCA). 15 July 2024
Generics
India-based generic drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for topiramate extended-release capsules. 15 July 2024
Pharmaceutical
Following its July 2024 meeting, the European Medicines Agency’s (EMA) safety committee (PRAC) has recommended new measures on the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs). 13 July 2024
Biosimilars
The mandate to conduct routine comparative clinical efficacy studies for biosimilar medicines, compounded by duplicative regional requirements, serves as a barrier to greater medicine access for patients, said the trade group International Generic and Biosimilar Medicines Association (IGBA). 13 July 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Third Quarter 2024 Biosimilar Market Report, which includes the latest Average Sales Price (ASP) information of all biosimilars and reference products available in the US market. 12 July 2024
Biotechnology
National Health Service (NHS) England has given approval to allow eligible patients access to Roche’s Ocrevus (ocrelizumab) subcutaneous injection for people with relapsing multiple sclerosis and primary progressive multiple sclerosis. 12 July 2024
Pharmaceutical
Shares of Texas, USA-based protein expert Salarius Pharmaceuticals fell more than 20% to $2.28 by close of trading on Thursday after the Food and Drug Administration (FDA) placed a study of the clinical-stage biopharmaceutical company's lead drug candidate on partial clinical hold. 12 July 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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