Regulation
Refine Search
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
Biotechnology
The US regulator has tapped Stanford University physician-scientist and former biotech executive George Tidmarsh to serve as director of its Center for Drug Evaluation and Research, CDER, stepping into a pivotal leadership role during a time of significant internal reshuffling. 22 July 2025
Pharmaceutical
The European Commission has granted marketing authorization in the European Union (EU) for German pharma major Bayer’s Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT), for a third therapeutic indication. 21 July 2025
Biosimilars
South Korea’s biosimilar drug developer Samsung Bioepis today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition reviewing the situation in the USA. 21 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, submitted by US pharma major Bristol Myers Squibb. 21 July 2025
Pharmaceutical
The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). 21 July 2025
Biotechnology
As of July 18, 2025, the Food and Drug Administration (FDA) said it has received three reports of fatal acute liver failure following treatment of patients with Sarepta Therapeutics’ AAVrh74 gene therapies that appear to have been caused by the gene therapy products as a result of acute liver failure. 19 July 2025
Biotechnology
The European Commission granted conditional marketing authorization for Ezmekly (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged two years and above. 19 July 2025
Pharmaceutical
Danish allergy immunotherapy specialist ALK has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved EURneffy 2 mg for anaphylaxis treatment of adults and children (≥30 kg). 18 July 2025
Biotechnology
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted against two proposed combination regimens containing GSK’s Blenrep (belantamab mafodotin), sending shares in the UK drugmaker tumbling by 5% Friday. 18 July 2025
article
A panel of health experts has called on the US regulator to remove boxed warnings from vaginal estrogen treatments, arguing the safety notice is no longer backed by current evidence and discourages patients from accessing effective menopause care. 18 July 2025
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
Swiss pharma giant Roche has won approval from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for its combination treatment of Columvi (glofitamab) alongside gemcitabine and oxaliplatin (GemOx) for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant. 17 July 2025
Pharmaceutical
Artificial intelligence has edged past the pilot phase in clinical development. Once a niche add-on, AI is now helping biopharma companies design, recruit, and run trials faster, cheaper, and—crucially—more inclusively. And regulators are starting to pay serious attention. 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
Pharmaceutical
Alnylam has secured expanded UK regulatory approval for Amvuttra (vutrisiran), broadening its indication to include treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults. 16 July 2025
Pharmaceutical
The UK government’s new life sciences plan has been met with skepticism by the pharmaceutical industry, which says the strategy will fall flat unless there is a serious shift in the way new medicines are funded and valued. 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
China-based Jiangsu Hengrui Pharma and US start-up Kailera Therapeutics, which is advancing a broad pipeline of next-generation therapies for the treatment of obesity, today announced positive top-line data from Hengrui’s Phase III clinical trial (HRS9531-301) of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China. 15 July 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze