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Pharmaceutical
Following marketing authorization by the European Commission in August for the same indication, the US Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. 23 December 2022
Biotechnology
Ahead of the expected December 29 action date, and adding to European approval in June, the US Food and Drug Administration (FDA) yesterday granted marketing authorization for Swiss pharma giant Roche subsidiary Genentech’s Lunsumio (mosunetuzumab-axgb). 23 December 2022
Generics
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
Biotechnology
Roche company Genentech has won US approval for its intravenous Actemra (tocilizumab) product, for adults that have been hospitalized with COVID-19. 22 December 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Applications (sBLAs) for Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) and Merck & Co’s Keytruda (pembrolizumab). 20 December 2022
Pharmaceutical
Switzerland-based Idorsia today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. 20 December 2022
Biotechnology
Chinese biopharma Hutchmed has started the filing of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib. 19 December 2022
Biotechnology
The US Food and Drug Administration has approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. 19 December 2022
Pharmaceutical
Big pharma pairing AstraZeneca and Merck & Co announced a rare setback with their blockbuster PARP inhibitor Lynparza (olaparib) in prostate cancer on Thursday. 16 December 2022
Biotechnology
As the year draws to a close, this article presents some of the wins of the orphan drug community in terms of US FDA approvals, while highlighting challenges faced by the sector and looking ahead to the expectations of the next year. 15 December 2022
Pharmaceutical
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Biotechnology
A second KRAS blocker has won US approval, opening further a market in oncology based on a target that was once thought undruggable. 13 December 2022
Biotechnology
On December 9, the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab), from Genentech, a USA-based subsidiary of Swiss pharma giant Roche, for adult and pediatric patients two years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 12 December 2022
Biosimilars
The US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) submitted by biotech major Biogen for BIIB800, a biosimilar candidate referencing Roche’s Actemra, an anti-interleukin-6 receptor monoclonal antibody. 12 December 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Investigational New Drug (IND) Application Annual Reporting proposed rule to replace the current regulations. 9 December 2022
Biotechnology
The world’s most popular coronavirus vaccine, Comirnaty, has received another positive regulatory decision in the USA. 9 December 2022
Biotechnology
USA-based clinical-stage biotech Akero Therapeutics (Nasdaq: AKRO) saw its shares gain 3.4% to $43.60 by close of trading yesterday, after it has announced that efruxifermin (EFX) has received a Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of non-alcoholic steatohepatitis (NASH). 9 December 2022
Biotechnology
Swedish biotech Oncopeptides saw its shares plunge 36% to 12.00 Swedish kronor yesterday, after it revealed that the US Food and Drug Administration (FDA) has requested a withdrawal of the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide). 8 December 2022
Biotechnology
Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate (ADC) developed by California’s Gilead Sciences, has performed well in a post hoc analysis of the Phase III TROPiCS-02 study. 7 December 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved a second indication for Brexafemme (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC). 6 December 2022
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
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 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 US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 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
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
Pharmaceutical
Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. 12 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, US vaccines developer Novavax revealed yesterday. 12 November 2024
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program, according to Sarah Wicks and James Valentine at US law firm Hyman, Phelps & McNamara. 11 November 2024
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
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