Regulation
Refine Search
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
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
The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for locally advanced or metastatic renal cell carcinoma patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). 5 June 2025
Biotechnology
German genetic medicine company ViGeneron has announced a rebrand to become VeonGen Therapeutics. 5 June 2025
Biotechnology
US rare disease meds developer Sarepta Therapeutics revealed that its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy type 2E/R4, has been granted platform technology designation by the US Food and Drug Administration. 5 June 2025
Pharmaceutical
China’s National Medical Products Administration approved its first domestically-developed nine-valent human papillomavirus (HPV) vaccine on Thursday. 5 June 2025
Biosimilars
Germany’s Formycon has announced that the Brazilian regulatory authority Anvisa has granted marketing authorization for FYB201/Ranivisio, a Lucentis (ranibizumab) biosimilar. 5 June 2025
Pharmaceutical
The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care. 5 June 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning to women taking popular medicines for weight loss and diabetes, sometimes referred to as “skinny jabs,” to use effective contraception while taking these medicines and, in some cases, for up to two months between stopping the medicine and trying to get pregnant. 5 June 2025
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published the UK’s first official guidance to support the safe development and use of phage therapies - treatments that use viruses to target and destroy harmful bacteria. 4 June 2025
Pharmaceutical
The European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA), Swiss pharma giant Roche revealed today 4 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
The American medicines regulator has approved Bayer’s Nubeqa (darolutamide) for broader use in patients with metastatic castration-sensitive prostate cancer (mCSPC), marking a step forward for the drugmakeFood and Drug Administraton,r’s prostate cancer franchise. 4 June 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib) for adults with non-small cell lung cancer (NSCLC). 3 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Biotechnology
Shanghai-based Mabwell Bioscience has secured approval from the Chinese regulator for its first locally developed novel biologic, marking a pivotal moment in the company's ambitions to expand its oncology pipeline and strengthen its commercial presence in Asia and beyond. 3 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
Biosimilars
In a website posting, the International Generic and Biosimilar medicines Association (IGBA) has commended the General Assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonization of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs." 2 June 2025
Biotechnology
Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025
Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 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