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Innovator and biosimilar drug approvals in 2024 down on prior year

The US Food and Drug Administration (FDA) announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023. 17 July 2025

GSK wins US approval for prefilled syringe version of shingles vaccine

UK pharma major GSK has gained US regulatory approval for a new prefilled syringe presentation of its shingles vaccine, Shingrix (zoster vaccine), a move aimed at streamlining administration and boosting immunization coverage. 17 July 2025

FDA probes ocular toxicity of Blenrep as GSK seeks new indications

UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025

FDA lifts partial hold on Kezar’s zetomipzomib trial

The Division of Hepatology and Nutrition of the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase IIa clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH), California, USA-based drug developer Kezar Life Sciences announced yesterday. 16 July 2025

FDA approves Biocon BLA for Kirsty

The US Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz, as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart), from Denmark’s Novo Nordisk. 16 July 2025

Kerendia approved in key new indication in USA

Germany’s Bayer has announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). 14 July 2025

US FDA's enhanced oversight signals long-term gains for Indian pharma

Even as the US Food and Drug Administration (FDA) has unveiled a strategic expansion of its oversight mechanisms for foreign manufacturing facilities supplying the American market, aiming to bolster product safety and ensure consistent quality for US consumers, the intensified oversight presents significant long-term benefits for the Indian pharmaceutical sector as a whole, reports The Pharma Letter’s India correspondent. 14 July 2025

The week in pharma: action, reaction and insight – week to July 11

The US Food and Drug Administration (FDA) last week authorized KalVista Pharmaceutical’s Ekterly for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. US President Donald Trump put out another warning on imposing tariffs on pharmaceutical products, albeit they may get a grace period of 10 months. US biopharma Rhythm Pharmaceuticals released encouraging Phase II results for its bivamelagon in acquired hypothalamic obesity. Also of note, AbbVie entered an up to $1.9 billion licensing deal with Ichnos Glenmark on autoimmune diseases. 13 July 2025

FDA slaps CRL on Capricor’s deramiocel BLA

US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for deramiocel, the company’s lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). 11 July 2025

Beyond the black box: rethinking adverse event prediction in light of the FDA’s push for AI transparency

Artificial Intelligence (AI) is reshaping pharmacovigilance, promising faster detection of safety signals hidden within mountains of adverse event (AE) data. However, as the US Food and Drug Administration (FDA) sharpens its focus on transparency, credibility, and real-world monitoring, the days of relying on opaque algorithms are numbered. In this article, we explore why sponsors and safety teams must rethink their approach to AE prediction to ensure the very tools designed to protect patients don’t become risks themselves. 11 July 2025

FDA grants approval for Spikevax in young children

The US Food and Drug Administration (FDA) has approved US mRNA specialist Moderna supplemental Biologics License Application (sBLA) for Spikevax, the company's COVID-19 vaccine, in children six months through 11 years of age who are at increased risk for COVID-19 disease. 11 July 2025

FDA to publish CRLs - albeit with a caveat

The US Food and Drug Administration (FDA) has taken the radical move of publishing more than 200 decision letters, known as complete response letters (CRLs). 10 July 2025

Merck & Co’s NDA for HIV regimen accepted by FDA

The US Food and Drug Administration (FDA) has accepted for review Merck & Co’s New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. 10 July 2025

FDA accepts Taiho’s sNDA for Inqovi

The US Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for Inqovi (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. 10 July 2025

New dosing approved for Lilly’s Kisunla in Alzheimer’s

The US Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Eli Lilly's once-monthly amyloid-targeting therapy for early symptomatic Alzheimer's disease (AD), including patients with mild cognitive impairment (MCI) and the mild dementia stage of AD, with confirmed amyloid pathology. 9 July 2025

Agencies up efforts to cut animal testing

The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have hosted a hybrid workshop on reducing animal testing. 9 July 2025

KalVista wins FDA greenlight for Ekterly

USA and UK-based KalVista Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Ekterly (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. 7 July 2025

The week in pharma: action, reaction and insight – week to July 4

US pharma major AbbVie announced it plan to acquire Capstan Therapeutics, along with its autoimmune disease candidate CPTX2309, for up to $2.1 billion. Organon posted disappointing mid-stage trial results for its investigational endometriosis pain drug, OG-6219. Also of note last week, the US Food and drug Administration (FDA) granted accelerated approval for Regeneron’s multiple myeloma drug Lynozyfic. 6 July 2025

FDA accelerated approval for Dizal’s sunvozertinib

The US Food and Drug Administration has granted accelerated approval to sunvozertinib (trade name Zegfrovy) from Dizal (Jiangsu) Pharmaceutical for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 3 July 2025

FDA steps up assessment of myocarditis following mRNA COVID-19 jabs

The US Food and Drug Administration (FDA) has provided an update on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men. 3 July 2025

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FDA approves first generic of Xarelto

The US Food and Drug Administration (FDA) has approved the first generics of Xarelto (rivaroxaban), a cardio vascular drug developed by Germany’s Bayer and marketed in the USA by Johnson & Johnson. 11 March 2025

US FDA faces calls for clarity on confirmatory trials

The US Food and Drug Administration has received a range of responses to its draft guidance on the Accelerated Approval pathway, with industry groups and advocacy organizations raising concerns about post-approval study requirements. 10 March 2025

FDA greenlight for Neurotech’s eye disease drug Encelto

The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Encelto (revakinagene taroretcel-lwey; NT-501) for the treatment of macular telangiectasia type 2 (MacTel), submitted by privately-held US biotech Neurotech Pharmaceuticals. 10 March 2025

The week in pharma: action, reaction and insight – week to March 7

Last week’s significant research news included positive new Phase III data on Tezspire in nasal polyps from Amgen and AstraZeneca. US pharma major AbbVie became the latest entrant to the weight management sector, striking a deal with Gubra for its obesity candidate GUB14295. On the M&A front, Ireland-headquartered Jazz Pharmaceuticals announced it is acquiring Chimerix for around $935 million to expand its oncology portfolio. USA-based scPharmaceuticals gained US Food and Administration (FDA) approval for its supplemental new drug application (sNDA) for Furoscix in chronic kidney disease (CKD). 9 March 2025

FDA approves first interchangeable biosimilar to Xolair

On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025

Trump’s FDA pick grilled over staff cuts, flu vaccine meeting

Marty Makary, nominated by Donald Trump to lead the Food and Drug Administration (FDA), has faced rigorous Senate scrutiny over recent agency job cuts and the abrupt cancellation of a flu vaccine advisory meeting. 7 March 2025

FDA nod for scPharmaceuticals’ Furoscix sNDA

Cardiorenal specialist scPharmaceuticals has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). 7 March 2025

ARS Pharma wins new FDA approval for neffy

ARS Pharmaceuticals’ shares closed up 3.4% at $10.87 yesterday, after the company announced that the US Food and Drug Administration (FDA) had approved neffy 1mg (epinephrine nasal spray) for a new indication. 6 March 2025

FDA places clinical hold on BioNTech malaria trial

German biotech major BioNTech has suffered a blow as it seeks to add new revenue streams beyond its COVID-19 vaccine, Comirnaty. 6 March 2025

FDA accepts Roche’s Gazyva/Gazyvaro sBLA for lupus nephritis

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis submitted by Swiss pharma giant Roche. 5 March 2025

Musk's FDA closures raise drug safety and oversight worries

The Department of Government Efficiency (DOGE), led by Tesla chief executive Elon Musk, has terminated leases for 30 US Food and Drug Administration facilities across the USA. 5 March 2025

New US approval for BeiGene’s Tevimbra

The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). 5 March 2025

FDA nod for two Celltrion denosumab biosimilars

South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s Prolia and Xgeva brands respectively for all indications of the reference products. 4 March 2025

FDA removes heart risk warning from testosterone products

The US Food and Drug Administration has issued new labeling changes for all approved testosterone replacement therapy products, removing a previous black box warning about cardiovascular risks while adding a new warning about increased blood pressure. 4 March 2025

FDA approves TNKase for stroke, offering rapid option

Genentech, part of the Roche group, has received a new approval from the US Food and Drug Administration for TNKase (tenecteplase). 4 March 2025

FDA RMAT designation for ImmunityBio’s Anktiva

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer. 3 March 2025

FDA approves ALK’s Odactra for young children

The US Food and Drug Administration (FDA) has approved Odactra tablet for use in young children with house dust mite (HDM) allergy, from Danish allergy expert ALK Abello. 28 February 2025

FDA priority review for Sobi’s Gamifant sBLA

The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg), submitted by Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi. 27 February 2025

FDA accepts sNDA for Arcutis’ Zoryve in young children with eczema

Immuno-dermatology specialist Arcutis Biotherapeutics closed Wednesday’s trading 8% higher. 27 February 2025

Odronextamab BLA resubmission accepted for FDA review

The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 26 February 2025

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