Latest Pharma and Biotech News
Pharmaceutical
14 January 2026 The US Food and Drug Administration yesterday approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. The FDA approved Zycubo, previously known as CUTX-101, for Sentynl Therapeutic, a part India’s Zydus Lifesciences which filed the regulatory filing and is partnered with Fortress Biotech.
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Pharmaceutical
The European Medicines Agency (EMA) recommended 104 medicines for marketing authorization in 2025. 15 January 2026
Pharmaceutical
India’s pharmaceutical sector enters 2026 at the threshold of a pivotal five-year phase, focused on building the ecosystem necessary to position itself as a global innovation hub, according to Home Minister Amit Shah, The Pharma Letter’s India correspondent reports. 15 January 2026
Pharmaceutical
Chinese-US biotech Vibrant Therapeutics said it has raised $61 million in new financing, taking total capital raised to $100 million. New investors include Pfizer Ventures and Apricot Capital, alongside Bayland Capital, HSG, Northern Light Venture Capital, and First Principle Venture Limited. 15 January 2026
Pharmaceutical
The Danish Novo Nordisk Foundation is allocating up to 5.5 billion Danish kroner ($860 million) to the BioInnovation Institute (BII), a Copenhagen-based organization set up to accelerate life science and deep tech innovation. The long-term funding framework runs from 2026 to 2035 and is intended to help BII support more entrepreneurs, expand into new scientific areas, and widen its European footprint. 15 January 2026
Biotechnology
Johnson & Johnson has announced positive top-line results from the investigational Phase III MajesTEC-9 study of Tecvayli (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% drop in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide. 15 January 2026
Biotechnology
Samsung Epis Holdings yesterday shared corporate progress and updates at the 44th JP Morgan Healthcare Conference. 15 January 2026
Pharmaceutical
After several months of collaboration, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a common set of 10 guiding principles to inform, enhance, and promote the use of artificial intelligence (AI) for generating evidence across all phases of the drug product life cycle. 15 January 2026
Biotechnology
Israeli pharma and generics player Teva, says the New England Journal of Medicine has published Phase III data from the SPACE trial showing Ajovy (fremanezumab-vfrm) reduced monthly migraine days and monthly headache days in children and adolescents with episodic migraine versus placebo. 15 January 2026
Pharmaceutical
US biotech Biogen said the European Commission on January 12, 2026 granted marketing authorization for a higher-dose regimen of Spinraza (nusinersen) to treat 5q spinal muscular atrophy. The EU label has been updated to include the dosing option. 15 January 2026
Pharmaceutical
US pharma major Bristol Myers Squibb has announced the appointment of Harald Hampel as senior vice president, worldwide head of medical affairs, Neuroscience. 14 January 2026
Biotechnology
US immunotherapy company ImmunityBio has announced that the Saudi Food and Drug Authority (SFDA) has granted accelerated approval of Anktiva (nogapendekin alfa inbakicept) for use alongside immune checkpoint inhibitors to treat adults with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following standard-of-care therapy. 14 January 2026
Biotechnology
Cambridge, USA-based clinical-stage biotechnology company Caldera Therapeutics, which is developing the first-in-class bispecific antibody CLD-423 for inflammatory bowel disease (IBD) and other immunologic and inflammatory diseases, today launched with $112.5 million total capital raised and announced that the first subjects have been dosed in the Phase I trial of its lead program, CLD-423. 14 January 2026
Biosimilars
Switzerland-based Sandoz, a global leader in affordable medicines, today confirmed that the European Commission has granted marketing authorization for Ondibta insulin glargine), a solution for injection in a pre-filled pen developed and registered by Gan & Lee Pharmaceuticals. 14 January 2026
Pharmaceutical
Of the billions that have been made and lost by investors in big pharma in the last two or three years, a significant chunk has involved the two biggest players in the burgeoning obesity field—Eli Lilly and Novo Nordisk. 14 January 2026
Pharmaceutical
US President Donald Trump’s recent warning of a 25% tariff on countries trading with Iran introduces fresh uncertainty for India’s economic engagement with the West Asian nation. 14 January 2026
Pharmaceutical
US commercial-stage biopharma Pelthos Therapeutics has secured a senior secured term loan facility of up to $50 million from Horizon Technology Finance (Nasdaq: HRZN), with $30 million funded at closing and up to $20 million available if certain milestones are met. 14 January 2026
Pharmaceutical
Maziar Mike Doustdar, the new president and chief executive of Danish pharma major Novo Nordisk, had the chance to set out his stall during a presentation at the JP Morgan Healthcare Conference on Tuesday. 14 January 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for French drugmaker Ipsen’s IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. 14 January 2026
Pharmaceutical
US pharma major Merck & Co is trying to make its looming Keytruda (pembrolizumab) patent hill look more like a speed bump. Speaking at the annual JPM conference, chief executive Rob Davis said the company now sees more than $70 billion in commercial opportunity from new growth drivers by the mid-2030s: up $20 billion from a year earlier. 14 January 2026
Biotechnology
Spanish dermatology specialist Almirall is using its appearance at the 44th JP Morgan Healthcare Conference in San Francisco to set out an active 2026 clinical agenda, leaning into proof-of-concept work across immune-driven skin diseases and pushing one bispecific antibody into first-in-human testing. 14 January 2026
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Biotechnology
Xiangxue Life Sciences has agreed a strategic partnership with Guangzhou-based Damien Vaccines to co-develop in vivo TCR-T therapies, adding fresh momentum to one of the cell-therapy field’s most closely watched next-generation strategies. 19 November 2025
Pharmaceutical
Bayer has opened its first China-based innovation center in Beijing’s E-Town BioPark, positioning the site as a launchpad for local biotechs aiming for global markets. The German pharma said the E-Town Open Innovation Center will integrate startups into its global network and strengthen China’s role in drug discovery. 19 November 2025
Biotechnology
US pharma major Merck has reported positive topline data from the Phase II Cadence trial, testing Winrevair (sotatercept-csrk) in adults with combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction. The study met its primary endpoint, cutting pulmonary vascular resistance versus placebo at 24 weeks. 19 November 2025
Generics
A new industry-supported study released for World AMR Awareness Week highlights widening gaps between falling antibiotic prices and sharply rising production costs. Published by Medicines for Europe, a trade group, the analysis reflects persistent concerns across Europe’s generic antibiotics market, which is valued at more than $10 billion. 19 November 2025
Pharmaceutical
US RNA interference (RNAi)specialist Arrowhead Pharmaceuticals, yesterday revealed that the US Food and Drug Administration (FDA) has approved Redemplo (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). 19 November 2025
Generics
The US Food and Drug Administration (FDA) published the final guidance for industry, “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.” 19 November 2025
Biotechnology
The European Commission has granted conditional marketing authorization of Roche’s Lunsumio (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 19 November 2025
Pharmaceutical
Australia’s CSL has announced plans to expand its US presence over the next five years, resulting in approximately $1.5 billion in capital investments. 18 November 2025
Biotechnology
The US Food and Drug Administration today announced it has approved Danish biotech firm Genmab’s Epkinly (epcoritamab-bysp) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). 18 November 2025
Pharmaceutical
Spanish plasma-based medicines producer Grifols today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for THROMBATE III, the company’s antithrombin III [human concentrate], to include pediatric patients diagnosed with hereditary antithrombin deficiency (hATd). 18 November 2025
Biotechnology
South Korean clinical-stage biotech ABL Bio has entered license, research and collaboration agreement with US pharma major Eli Lilly for the development of therapeutics by utilizing ABL Bio’s Grabody Platform. 18 November 2025
Pharmaceutical
A major British initiative is set to repurpose used nuclear materials, converting them into a consistent supply for innovative cancer treatments. The £9.9 million ($13 million) from the Innovate UK SMMIP, plus £8.9 million from industry, is backing the development of Targeted Alpha Therapies. 18 November 2025
Biosimilars
Swiss generics and biosimilars company Sandoz has announced the launch of Tyruko (natalizumab-sztn) in the USA. 18 November 2025
Biosimilars
South Korean biosimilars developer Celltrion today announced that the European Commission (EC) has granted marketing authorization for Remsima IV (intravenous) liquid formulation, the world’s first liquid formulation of IV infliximab. 18 November 2025
Pharmaceutical
Shares of US clinical-stage biopharmaceutical company Nuvalent jumped more than 15% to $111.22 by midday yesterday, after it announced positive top-line pivotal data for neladalkib. 18 November 2025
Biotechnology
Canadian firm Zymeworks, a biotech managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, has announced a new strategy. 18 November 2025
Pharmaceutical
US industry group PhRMA says three years of Inflation Reduction Act implementation have coincided with rising Medicare Part D premiums, fewer standalone plans and growing barriers to treatment. 18 November 2025
Pharmaceutical
New government funding will help make the boldest ideas in UK life sciences a reality – from putting robots to work in factories making medicines, to turning spent nuclear fuel into the next generation of cancer therapies. 18 November 2025
Pharmaceutical
Roche today announced positive Phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. 18 November 2025
Biosimilars
Germany’s Formycon has announced details of one of its previously undisclosed development projects in the shape of FYB208, a biosimilar candidate for the immunological drug Dupixent (dupilumab). 17 November 2025
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