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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
Biotechnology
The US Food and Drug Administration has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. 10 February 2021
Biotechnology
A key scientific panel of the US medicines regulator has voted unanimously to wait for more data before deciding on a bid to broaden the label for Keytruda (pembrolizumab). 10 February 2021
Biotechnology
On Friday, the US Food and Drug Administration granted accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon. 8 February 2021
Biotechnology
The US Food and Drug Administration on Friday at last approved Breyanzi (lisocabtagene maraleucel – liso-cel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. 8 February 2021
Biotechnology
Janssen Biotech has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. 5 February 2021
Biotechnology
The US Food and Drug Administration is again alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. 5 February 2021
Pharmaceutical
Californian biopharma Durect Corporation has announced that the US Food and Drug Administration (FDA) has approved Posimir (bupivacaine solution). 3 February 2021
Biotechnology
The US regulator has accepted for review a submission from American biotech VBI Vaccines, for a hepatitis B vaccine candidate. 2 February 2021
Pharmaceutical
Clinical research was again a strong feature of news last week, not only on the COVID-19 front, as Roche presented new Phase III data showing its wet age-related macular-degeneration candidate faricimab was non-inferior to market leader Eylea. The USA’s Merck & Co has abandoned development of two COVID-19 vaccine candidates – V590 and V591. US biotech Moderna presented evidence that its COVID-19 vaccine candidate mRNA-1273 was effective against some of the new variants of the virus – but was taking no chances and instigated a new trail to access efficacy in the South Africa variant. Regeneron also presented new data on its COVID-19 offering – REGEN-CoV (casirivimab and imdevimab), with positive results on infection prevention. On the regulatory front, Aurinia Pharmaceutical had a boost last Monday, after the US Food and Drug Administration granted approval for its lupus nephritis drug Lupkynis. 31 January 2021
Biotechnology
US biotech Biogen and Japanese partner Eisai today announced that the US Food and Drug Administration has extended the review period by three months for their Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. 29 January 2021
Generics
The US Food and Drug Administration issued a warning letter to Professional Compounding Centers of America (PCCA) for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs). 28 January 2021
Biotechnology
A post-marketing safety study of Pfizer’s Xeljanz (tofacitinib) has missed both primary endpoints, threatening to undermine the drug’s competitiveness among rival options. 28 January 2021
Pharmaceutical
Recordati has announced that the US Food and Drug Administration (FDA) has approved a new indication for Carbaglu (carglumic acid) tablets 200mg. 27 January 2021
Biotechnology
Boston, USA-based Albireo Pharma - a spinoff of UK-based AstraZeneca - is moving ahead with the regulatory process for odevixibat. 25 January 2021
Pharmaceutical
The US Food and Drug Administration has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). 25 January 2021
Pharmaceutical
The US Food and Drug Administration yesterday approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. 22 January 2021
Biotechnology
Shares of US biotech firm Incyte edged up 1.5% to $95.34 pre-market, after the company said late yesterday that the US Food and Drug Administration has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab (previously known as MGA012),. 22 January 2021
Pharmaceutical
The US Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). 21 January 2021
Pharmaceutical
Novo Nordisk has sought a label expansion application from the US Food and Drug Administration (FDA) for the existing marketing authorization for Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2mg. 21 January 2021
Pharmaceutical
A new product will enter the increasingly competitive cardiovascular space, with approval in the USA for Merck & Co and Bayer’s Verquvo (vericiguat). 21 January 2021
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