Regulation
Refine Search
Pharmaceutical
The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan). 29 April 2025
Biotechnology
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
Biotechnology
Shares of French speciality vaccines developer Valneva were down 8.4% at 2.89 euros by early afternoon, after it announced a negative decision by France’s national public health agency. 28 April 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) late Friday announced it has granted a conditional marketing authorization for the Aucatzyl (obecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 28 April 2025
Pharmaceutical
Seeking to ensure the quality and safety of pharmaceutical products, India's regulatory bodies have intensified their crackdown on substandard and spurious drugs. The move comes at a crucial juncture as the country inches closer to establishing a comprehensive regulatory framework for over-the-counter (OTC) medications, reports The Pharma Letter’s India correspondent. 28 April 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Beyonttra (acoramidis), from Germany’s Bayer, to treat adult patients with cardiomyopathy (damage to the heart muscle) caused by variant or wild-type transthyretin amyloidosis (ATTR-CM). 26 April 2025
Pharmaceutical
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months. 26 April 2025
Biotechnology
The European Commission (EC) has approved a marketing authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 25 April 2025
Pharmaceutical
A new analysis by Charles River Associates, commissioned by European industry group EFPIA, suggests that a proposed reward system for antibiotic developers could be significantly cheaper for EU governments than previously estimated by the European Commission. 25 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
Biotechnology
US biopharma Novavax closed 20% higher on Wednesday after announcing an update on its COVID-19 vaccine. 24 April 2025
Pharmaceutical
Shares in Eli Lilly shot up last Thursday after the US pharma major announced positive top-line Phase III results from ACHIEVE-1, comparing orforglipron to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. 23 April 2025
Pharmaceutical
Denmark-based allergy immunotherapy specialist ALK Abello today announced that its Itulazax (tree pollen sublingual allergy immunotherapy tablet) has been approved by the European regulator for treatment of young children and adolescents aged five to 17. 23 April 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Hympavzi (marstacimab) to prevent or reduce bleeding in patients 12 years of age and older weighing at least 35kg with hemophilia A and B. 22 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted another approval for Dupixent (dupilumab), for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. 19 April 2025
Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Pharmaceutical
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). 17 April 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
Pharmaceutical
Swissmedic has introduced a fast-track review process for clinical trial applications, aiming to speed up access to innovative treatments in Switzerland. 7 July 2025
Pharmaceutical
Last week’s announcement of a Life Science Strategy from the European Commission, includes action to address long-standing issues that have been hampering the region’s competitiveness and preventing European patients from accessing the latest advances in treatment. The Strategy represents a very welcome step forward for life science companies operating in Europe. 7 July 2025
Pharmaceutical
A Dutch appeals court has ruled that health insurers acted unlawfully in their group tender for three CDK 4/6 inhibitors, reigniting debate over cost-driven drug policies in the Netherlands. The case centered on whether insurers can restrict prescribing choices for innovative cancer drugs that differ in clinical profiles. 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
Pharmaceutical
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. 4 July 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Vevzuo and Evfraxy biosimilars of denosumab, originated by Amgen. 4 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
A federal judge has blocked the US Department of Health and Human Services from moving forward with a major workforce reduction and agency overhaul, finding that the changes may violate federal law and cause lasting disruption. 2 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
Alnylam Pharmaceuticals has won European Commission approval for Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM), positioning the drug as a likely challenger to entrenched therapies in a market expected to see rapid evolution. 2 July 2025
Biotechnology
US biotech Jazz Pharmaceuticals yesterday announced that the European Commission (EC) has granted conditional marketing authorization for Ziihera (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, with the news edging its shares up 3.1% to $109.44. 2 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. 2 July 2025
Pharmaceutical
Vertex Pharmaceuticals today announced that the European Commission has granted approval for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) ages six years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 1 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
A Republican-backed amendment to the sweeping budget proposal championed by US president Donald Trump would sharply reduce Medicaid spending, targeting one of the core features of the Affordable Care Act. 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
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