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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
Pharmaceutical
Shares of Travere Therapeutics fell 15.8% to $21.15 in after-hours trading, as the company revealed that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for traditional approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS), but with an unexpected glitch. 16 May 2025
Biotechnology
Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the US Food and Drug Administration (FDA), said the drug’s developer, AbbVie. 15 May 2025
Biotechnology
Japanese pharma major Takeda announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Vonvendi [von Willebrand factor (Recombinant)] for investigational routine prophylactic use in adults (age 18 years and older) with von Willebrand disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative use in children with VWD. 15 May 2025
Pharmaceutical
The US Food and Drug Administration approved Welireg (belzutifan), from US pharma giant Merck & Co, for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). 15 May 2025
Biotechnology
UK-based Kaerus Bioscience, a biopharma created by European investment firm Medicxi for the development of therapeutics for rare genetic syndromes of neurodevelopment, has announced that its lead candidate KER-0193 has been granted both Orphan Drug Designation and Rare Pediatric Drug Designations for the treatment of Fragile X syndrome (FXS) by the US Food and Drugs Administration (FDA). 14 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy, Boston, said USA-based. Verastem Oncology, whose shares rose 3.7% to $6.94 on the news. 9 May 2025
Biotechnology
The American medicines regulator will convene its vaccine advisory committee on May 22 to weigh in on which strains should be used for the next round of COVID-19 booster shots, amid heightened interest in the new administration’s stance toward vaccines. 8 May 2025
Biotechnology
California-based Atara Biotherapeutics revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold on its active Investigational New Drug (IND) applications for the Ebvallo (tabelecleucel) program, sending the firm’s share up 5.8% to $7.67. 7 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. 7 May 2025
Biotechnology
US ophthalmics-focused biotech Opus Genetics today revealed that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber congenital amaurosis (LCA) due to genetic variations in the LCA5 gene. 6 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) accepted Novo Nordisk’s New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease. 6 May 2025
Biosimilars
Teva Pharmaceutical Industries’ US subsidiary and Iceland-based Alvotech (Nasdaq: ALVO) today announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). 5 May 2025
Pharmaceutical
May 2, 2025
Clinical-stage biopharma company Satsuma Pharmaceuticals and its corporate parent, Shin Nippon Biomedica, announced that they have received US Food and Drug Administration (FDA) approval for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101. 2 May 2025
Pharmaceutical
The US Department of Health and Human Services has announced a sweeping change to the way new vaccines are evaluated, saying it will now require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 2 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG), from US healthcare giant Johnson & Johnson. 1 May 2025
Biotechnology
UK pharma major GSK has published results from its Phase III MATINEE trial evaluating Nucala (mepolizumab) in patients with chronic obstructive pulmonary disease, as it awaits a US decision on whether the drug can be approved for this use. 1 May 2025
Biotechnology
Chicago-based drugmaker AbbVie has announced the US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), 15mg, once daily, for the treatment of adults with giant cell arteritis (GCA). 30 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, from US gene therapy developer Abeona Therapeutics. 30 April 2025
Biotechnology
The US Food and Drug Administration (FDA) approved penpulimab-kcqx, from little known Chinese biotech Akeso Biopharma, with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). 25 April 2025
Biotechnology
US biotech Equillium’s shares fell by 3% to $0.47 after the company announced that the US Food and Drug Administration (FDA) declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for its drug itolizumab, intended for the treatment of acute graft-versus-host disease (aGVHD). 25 April 2025
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