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Pharmaceutical
The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug Application (NDA) for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) due to menopause. 26 July 2025
Biotechnology
As if there had not been enough negative news regarding Elevidys (delandistrogene moxeparvovec) this month, there was more today from the European regulator. 25 July 2025
Pharmaceutical
The European Medicines’ (EMA) human medicines committee (CHMP) has recommended seven novel medicines for approval at its July 2025 meeting. 25 July 2025
Biotechnology
French drugmaker Ipsen announced that the European Commission (EC) has approved Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. 25 July 2025
Pharmaceutical
The Trump administration has asked the US Supreme Court to allow the National Institutes of Health (NIH) to resume canceling hundreds of research grants supporting work on health equity, racial disparities, and other diversity-related public health initiatives. 25 July 2025
Biotechnology
In an import contrast to events in the USA, UK pharma major GSK late Thursday announced the approval of Blenrep (belantamab mafodotin) by the European Commission. 25 July 2025
Biotechnology
Following the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on June 19, 2025, the European Commission has approved French pharma major Sanofi's (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. 25 July 2025
Generics
Hospitals are rationing cancer treatments. Pharmacies are scrambling to fill routine antibiotic prescriptions. And across the USA, patients are facing growing delays, substitutions, or outright denials of essential medicines, not because the drugs don’t exist, but because the supply chains behind them have buckled. 24 July 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved US pharma major AbbVie’s Elahere (mirvetuximab soravtansine) to treat adults with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 24 July 2025
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma today revealed that the US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 24 July 2025
Biotechnology
Swiss pharma giant Roche has paused shipments of the gene therapy Elevidys (delandistrogene moxeparvovec) for new orders in certain countries outside the USA. 24 July 2025
Biotechnology
US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota, formerly known as AOC 1044), the company’s investigational therapy for the treatment of people with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44). 24 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for GSK’s Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 24 July 2025
Biotechnology
US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the European Commission (EC) has approved a new indication and an indication extension for Darzalex (daratumumab) and Imbruvica (ibrutinib), respectively. 23 July 2025
Pharmaceutical
Privately-held Spanish CNS specialist Minoryx Therapeutics and Germany’s Neuraxpharm Group today announced that the marketing authorization application (MAA) for Minoryx’ lead candidate Nezglyal (leriglitazone) has been submitted to the European Medicines Agency (EMA) for the treatment of pediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). 23 July 2025
Biotechnology
The European Commission has approved Swiss pharma giant Roche’s Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. 23 July 2025
Biotechnology
Patients in the UK will now be able to access advanced, personalized treatments prepared at the hospital or even in mobile units near their homes, thanks to a world-first regulatory shift. New legislation introduced by the country’s drug regulator allows hospitals and care centers to produce small or individual batches of cutting-edge therapies at the point of care. 23 July 2025
Biotechnology
French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025
Biotechnology
Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025
Biotechnology
Shares in Sarepta Therapeutics have slumped by more than a third since late last week amid new updates on its gene therapy development woes. 22 July 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Ekterly (sebetralstat) 0for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. 15 July 2025
Biotechnology
A quiet shift with potentially big implications for cancer drug access is underway in the UK. In June, the country’s health technology assessor, NICE, recommended GSK’s Blenrep (belantamab mafodotin) in multiple myeloma. 14 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
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of Bayer's Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 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
Biosimilars
South Korea’s Samsung Bioepis today published a whitepaper titled ‘Solving the Biosimilar Void in Europe’ that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. 14 July 2025
Pharmaceutical
US biotech Crinetics Pharmaceuticals has released new data on its investigational oral therapy Palsonify (paltusotine), supporting its potential as a convenient alternative to monthly injections for patients with acromegaly. 14 July 2025
Biotechnology
Ultragenyx Pharmaceutical has been dealt a regulatory setback, as the American medicines regulator has declined to approve its gene therapy UX111 (formerly ABO-102) for Sanfilippo syndrome type A. The decision, delivered in a complete response letter, will delay any potential approval until at least 2026. 14 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
At its July meeting, the European Medicines Agency’s pharmacovigilance committee (PRAC) completed its review of French specialty vaccine maker Valneva Ixchiq (chikungunya virus vaccine, a live attenuated chikungunya vaccine, following reports of serious side effects. 11 July 2025
Biotechnology
Sino-American biopharma Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China’s National Medical Products Administration (NMPA). 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
Biotechnology
The European Commission has approved Tevimbra (tislelizumab), alongside gemcitabine and cisplatin, for the first-line treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. 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
Pharmaceutical
The USA’s Federal Trade Commission is sending payments totaling more than $409,000 to consumers who bought products from weight-loss supplement marketer Roca Labs. 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
US antivirals specialist Gilead Sciences today announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir - Gilead's twice-yearly injectable HIV-1 capsid inhibitor - for the prevention of HIV as pre-exposure prophylaxis (PrEP). 9 July 2025
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