Regulation
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Pharmaceutical
The US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submission for suzetrigine (VX-548). 31 July 2024
Pharmaceutical
As part of its regular benchmarking exercise, Swissmedic has concluded that other major medicines regulators, notably in Europe and the USA, are able to process regulatory submissions in less time. 30 July 2024
Pharmaceutical
Shares in North Carolina, USA-based vTv Therapeutics (Nasdaq: VTVT) have fallen over a quarter after the firm announced a clinical hold on its diabetes program. 30 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has given its approval to Alpha Cognition’s oral therapeutic, Zunveyl (benzgalantamine), for the treatment of Alzheimer's disease (AD). 30 July 2024
Biotechnology
The European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. 30 July 2024
Pharmaceutical
Spanish drugmaker Grifols, one of the world’s leading producers of plasma-derived medicines, has announced that the US Food and Drug Administration (FDA) has approved an expanded label for Xembify, the company’s 20% subcutaneous immunoglobulin (SCIg), to include treatment-naïve patients with primary humoral immunodeficiencies (PI). 29 July 2024
Pharmaceutical
Aphria RX has received a trading license, which will allow it to sell and distribute a broad range of medical cannabis products in Germany. 29 July 2024
Pharmaceutical
The US Food and Drug Administration’s (FDA) Office of New Drugs (OND), part of the Center for Drug Evaluation and Research (CDER), plays a pivotal role in advancing public health by facilitating access to novel, effective and safe drugs that address unmet clinical needs. 29 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) had approved its Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe 29 July 2024
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has adopted positive opinions for six biosimilar medicines. 27 July 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines for approval at its July 2024 meeting. 26 July 2024
Biotechnology
In the UK, the health technology assessor has ruled in favor of reimbursing a new use for Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab). 26 July 2024
Biotechnology
EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab). 26 July 2024
Pharmaceutical
Viking Therapeutics plans to advance its experimental weight loss injection into a late-stage trial earlier than expected. 26 July 2024
Biotechnology
An advisory panel of the US Food and Drug Administration has questioned the design of a trial for AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab), while confirming that it met the primary efficacy goal. 26 July 2024
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), from US pharma giant Pfizer 25 July 2024
Biotechnology
Californian drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) has announced that the US Food and Drug Administration has approved a label expansion for Brineura (cerliponase alfa). 25 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
Pharmaceutical
The US medicines regulator has issued a warning letter to Indian contract development and manufacturing organization (CDMO) Brassica Pharma for severe data integrity violations at its manufacturing facility in Thane. 24 July 2024
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
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
Biotechnology
Dutch firm Argenx and China’s Zai Lab have received an approval from the National Medical Products Administration (NMPA) for Vyvgart Hytrulo (efgartigimod alfa). 13 November 2024
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