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Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Tepezza (teprotumumab (Tepezza). 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
UK pharma major AstraZeneca today revealed that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. 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
Pharmaceutical
The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Vimkunya, a vaccine used to prevent disease caused by the chikungunya virus in people 12 years of age and older. 2 May 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s Opdivo (nivolumab) in a new formulation associated with a different route of administration (subcutaneous use), an alternative pharmaceutical form (solution for injection) and a new strength (600mg/vial). 1 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
UK regulators are set to review a proposed label update for Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), potentially opening the door to a once-monthly maintenance dosing option. 1 May 2025
Biotechnology
US biotech firm Stealth BioTherapeutics is facing renewed uncertainty after the American medicines regulator failed to deliver a decision on the company’s new drug application for elamipretide, its potential treatment for Barth syndrome, by the expected April 29 deadline. 30 April 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
Pharmaceutical
US-Ireland drugmaker Shorla Oncology has received approval from the US regulator for a new multi-dose vial of Tepylute (thiotepa), a chemotherapy treatment for breast and ovarian cancers. 30 April 2025
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
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
Pharmaceutical
Swedish biotech Camurus has secured EU marketing authorization for its once-monthly acromegaly therapy, Oczyesa (octreotide), marking a significant step forward in treatment convenience for patients living with the rare endocrine disorder. 1 July 2025
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