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Biotechnology
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
Biotechnology
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
Biotechnology
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025
Biotechnology
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
Biosimilars
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
Pharmaceutical
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
Generics
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody. 3 July 2025
Biotechnology
US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) to update the US product label for Winrevair (sotatercept-csrk) based on the Phase III ZENITH trial. 2 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Unicycive Therapeutics’ New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, but still sending the California-based company's share shares nearly 5% higher to $5.00. in pre-market activity. 1 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD)—including certain formulations of amphetamine and methylphenidate—to warn of the risk of weight loss and other adverse reactions in patients younger than six years. 1 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies. 30 June 2025
article
Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi on Frida,y announced that the US Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for a new indication, edging the company’s shares up 2.4% to 284.60 kronor. 28 June 2025
Biotechnology
US pharma major Merck & Co has secured a key endorsement for its newly approved respiratory syncytial virus (RSV) prevention product, Enflonsia (clesrovimab), as a majority of an influential advisory panel voted to recommend its use in newborns ahead of the 2025-2026 RSV season. 27 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer and Spikevax (COVID-19 Vaccine, mRNA) manufactured Moderna to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. 26 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (previously known as EG-70), Canadian company enGene’s lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). 26 June 2025
Pharmaceutical
Republican Senator Bill Cassidy has called for Wednesday’s meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) to be delayed. 25 June 2025
Pharmaceutical
Nuvalent, a US biopharma developing precisely targeted therapies for clinically-proven kinase targets in cancer, has announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). 24 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan or Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. 24 June 2025
Biotechnology
The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 countries, including emerging and established biotech firms, has taken aim at the powers that be in US healthcare. 23 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Pharmaceutical
Privately-held UK firm Cycle Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). 20 June 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Gilead Sciences Yeztugo (lenacapavir) - the company’s injectable HIV-1 capsid inhibitor - as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. 19 June 2025
Biotechnology
The US Food and Drug Administration has approved US biotech Incyte’s Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 19 June 2025
Biotechnology
The biopharmaceutical industry is grappling with a complex mid-year outlook in 2025, as accelerating innovation collides with mounting policy and market uncertainty. From US drug pricing reforms to global tariff tensions, sentiment has taken a hit - reflected in a 16% drop in industry optimism. 19 June 2025
Biotechnology
EY today released its 35th annual Biotech Beyond Borders Report. This finds that the biopharma industry is currently at an inflection point – grappling with a unique environment of macroeconomic uncertainty and constrained access to capital, including high interest rates, inflation, shifting regulatory policies and tariff turmoil. 18 June 2025
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