Regulation
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Biotechnology
Singapore-based Specialised Therapeutics has secured approval for Zepzelca (lurbinectedin) with Roche’s Tecentriq (atezolizumab) as a first-line maintenance treatment for extensive-stage small cell lung cancer in Australia and Singapore, extending the regimen into earlier use in the treatment pathway. 23 April 2026
Biotechnology
The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. 23 April 2026
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants up to 12 months of age throughout their first RSV season. 22 April 2026
Pharmaceutical
US pharma major Merck & Co has secured approval for Idvynso (doravirine/islatravir), a once-daily single-tablet regimen for adults with virologically suppressed HIV-1, offering a new option for patients switching from existing antiretroviral therapies. 22 April 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved Sanofi’s supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. 22 April 2026
Biotechnology
US biotech Moderna (today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX (mRNA-1083), the company's mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. 21 April 2026
Biotechnology
The US Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) submitted by Japan’s Astellas Pharma and US pharma .giant Pfizer. 21 April 2026
Pharmaceutical
UK biotech Compass Pathways saw its shares jump 42% after a White House executive order signaled a more permissive US stance on psychedelic treatments for mental illness. 21 April 2026
Biotechnology
British pharma GSK has won approval in China for Blenrep (belantamab mafodotin) with bortezomib and dexamethasone in relapsed or refractory multiple myeloma after at least one prior therapy. 21 April 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). 21 April 2026
Pharmaceutical
The US Food and Drug Administration (FDA) is ramping up government efforts to curb misinformation on prescription drugs that endanger public health. This is in line with the presidential memorandum, which seeks to address misleading direct-to-consumer (DTC) prescription drug advertisements. 20 April 2026
Pharmaceutical
Swiss industry group Interpharma has called for the country to maintain and expand its bilateral framework with the European Union, warning that political proposals affecting migration could disrupt the pharmaceutical sector. 20 April 2026
Pharmaceutical
Regulators in the USA, Europe and Asia used the past week to push through a mix of technical guidance, supply interventions and operational changes, with relatively few headline drug approvals. 20 April 2026
Biotechnology
Among regulatory news last week, US biotech Replimune had another US Food and Drug Administration (FDA) setback for its investigational cancer drug RP1 (vusolimogene oderparepvec). But the FDA granted approval for Travere Therapeutics’ Filspari for the treatment of focal segmental glomerulosclerosis. Eli Lilly posted new clinical data on its Foundayo and said it would file for FDA approval of the drug in diabetes. On the M&A front, Belgium’s UCB announced an up to $2.15 billion bid for Neurona Therapeutics and its epilepsy candidate NRTX-1001. 19 April 2026
Biotechnology
US pharma giant Merck & Co, known as MSD outside of the USA and Canada, today announced that the European Commission (EC) has approved Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season. 17 April 2026
Pharmaceutical
US President Donald Trump has nominated Erica Schwartz to lead the Centers for Disease Control and Prevention (CDC) after a long search for a replacement for Susan Monarez, who was sacked in August last year. 17 April 2026
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER), in collaboration with Verdant Research, has published a new white paper that examines the evolution – and perception – of the Food and Drug Administration (FDA) accelerated approval pathway. 16 April 2026
Pharmaceutical
The US Food and Drug Administration will ask outside advisers in July whether some peptide substances should be allowed on the 503A Bulks List, a step that could reopen debate over compounded products now popular in wellness and performance circles. 16 April 2026
Biotechnology
Privately-held Swiss drug firm Ewopharma has reported that sugemalimab, licensed from Chinese partner CStone Pharmaceuticals, has received I, A recommendation in the European Society for Medical Oncology (ESMO) Early and Locally Advanced Non-Small-Cell Lung Cancer Living Guideline. 16 April 2026
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abello today announced that Health Canada has approved Neffy 2mg adrenaline (epinephrine) nasal spray for the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in adult and paediatric patients (≥30 kg). 15 April 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory sandbox to examine how artificial intelligence (AI) could support medicines development and drug safety assessment. 9 June 2026
Pharmaceutical
European vaccine policy led a relatively quiet week for global medicines regulation, with the European Medicines Agency recommending that COVID-19 vaccines be updated to target the XFG variant for the 2026/2027 vaccination campaign. 9 June 2026
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) released a Fina; Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (TAK-861), from Japan’s Takeda Pharmaceutical for narcolepsy type 1. 9 June 2026
Biotechnology
US pharma giant Pfizer today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. 8 June 2026
Biotechnology
The European Commission has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation. 8 June 2026
Pharmaceutical
Among licensing news of note last week, US drug developer Agios Pharma struck a deal with South Korea’s Oscotec for the latter’s cevidoplenib, a potential treatment for immune thrombocytopenia. US major AbbVie won European Commission approval for its migraine drug Aquipta. Travere Therapeutics licensed rights to civorebrutinib from China’s Everest Medicines, and Alnylam Pharmaceuticals entered into an AI collaboration with Inceptive Nucleics worth a potential $2 billion. 7 June 2026
Pharmaceutical
Chiesi Global Rare Diseases, a unit of privately-held Italian drugmaker Chiesi, announced that the European Commission (EC) has approved Lojuxta (lomitapide) capsules for use in children 5 years of age and older with homozygous familial hypercholesterolemia (HoFH), for use alongside diet and other lipid-lowering treatments, including LDL-apheresis where available. 6 June 2026
Biotechnology
US biotech Biogen has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for salanersen, its investigational antisense oligonucleotide for spinal muscular atrophy (SMA). 5 June 2026
Generics
The US Supreme Court has handed a unanimous win to British drugmaker Hikma in a closely watched generics patent case brought by Irish biopharma Amarin. 5 June 2026
Biotechnology
US drugmaker Gilead Sciences today announced that the UK’s National Institute for Health and Care Excellence (NICE) has approved Livdelzi (seladelpar) for the use on the National Health Service (NHS) in England within its marketing authorization as an option for treating primary biliary cholangitis (PBC). 4 June 2026
Pharmaceutical
Shares of US biopharma company Cingulate closed up 11.9% at $4.03 on Tuesday, after it announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for its New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) for the treatment of attention deficit/hyperactivity disorder (ADHD). 4 June 2026
Biotechnology
US biotech Iovance Biotherapeutics, which is developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma. 4 June 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized US biopharma Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) to treat adult patients with metabolic dysfunction-associated steatohepatitis (MASH). 4 June 2026
Biotechnology
The US Food and Drug Administration has issued draft guidance designed to help cell and gene therapy developers make greater use of existing scientific and regulatory knowledge, a move aimed at trimming redundant testing without lowering safety standards. 3 June 2026
Pharmaceutical
US pharma major AbbVie announced that the European Commission (EC) has approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed (PRN). 3 June 2026
Pharmaceutical
In this week’s Expert View, Cem Zorlular, CEO of Er-Kim, argues that Europe’s W.A.I.T. indicator is becoming too blunt to capture how patients actually access medicines. He says the index risks deterring investment in markets where viable access routes already exist. 3 June 2026
Biotechnology
Australia’s CSL Ltd today announced that the European Commission has granted marketing authorization for Privigen, a human immunoglobulin therapy indicated for pre- and post-exposure prophylaxis to prevent and reduce the risk of measles where vaccination is contraindicated or not recommended. 2 June 2026
Biotechnology
US biotech major Amgen yesterday announced that the European Commission (EC) has granted marketing authorization for Imdylltra (tarlatamab) as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy. 2 June 2026
Pharmaceutical
The US Food and Drug Administration (FDA) published a final guidance for industry, “Pulmonary Tuberculosis: Developing Drugs for Treatment.” 2 June 2026
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