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Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 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
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC). 14 March 2024
Pharmaceutical
Pfizer has won European Commission (EC) approval for Prevenar 20 for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in children aged from six weeks to less than 18 years. 13 March 2024
Pharmaceutical
Following discussions with the US regulator, Texan drugmaker Lexicon Pharmaceuticals now plans to resubmit a New Drug Application (NDA) for sotagliflozin. 12 March 2024
Pharmaceutical
USA-based Viatris said in a website posting that it has been informed by its partner, Israel-based Mapi Pharma, that it has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40mg from the US Food and Drug Administration (FDA). 12 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
Pharmaceutical
On Monday, the US Food and Drug Administration (FDA) issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. 12 March 2024
Biotechnology
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
Biosimilars
German biosimilars company Formycon and Jordan-based MS Pharma have announced that FYB201, a biosimilar to Lucentis (ranibizumab), has received marketing authorization from the Saudi Food and Drug Authority. 11 March 2024
Biotechnology
Polish cell therapy company PolTREG has received a Current Good Manufacturing Practice (cGMP) certificate, allowing it to produce advanced therapies at its own facility. 11 March 2024
Pharmaceutical
Data protection is in the spotlight in Europe, as lawmakers gather to decide on an important set of rules on intellectual property, the Regulatory Data Protection (RDP) law. 11 March 2024
Generics
Brazil’s Institute of Drug Technology (Farmanguinhos/Fiocruz) has announced a partnership agreement with the Brazilian unit of the German family-owned pharma major Boehringer Ingelheim. 11 March 2024
Pharmaceutical
In another win for Denmark’s Novo Nordisk, the US Food and Drug Administration approved a new indication for use for its Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. 9 March 2024
Biotechnology
US drugmaker Eli Lilly had expected to hear whether its amyloid plaque-targeting therapy donanemab had been approved in the USA to treat early symptomatic Alzheimer's disease by the end of last year. 8 March 2024
Biotechnology
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. 8 March 2024
Pharmaceutical
Shares in Mind Medicine were nearly 52% higher following Thursday's trading. 7 March 2024
Biotechnology
A key committee of the US Senate has given its stamp of approval for the BIOSECURE Act, which aims to prevent contracts with Chinese biotech companies. 7 March 2024
Biotechnology
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 7 March 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Rystiggo (rozanolixizumab), from Belgium’s largest drug maker UCB. 7 March 2024
Biotechnology
UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC). 7 March 2024
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