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Danish pharma major Novo Nordisk on Saturday unveiled new data from the Phase III FRONTIER4 extension study evaluating the long-term safety and efficacy of investigational denecimig (Mim8) subcutaneous prophylaxis in children, adolescents, and adults with hemophilia A. 13 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. 10 July 2026
Biotechnology
The European Commission has approved Danish biotech Genmab and US pharma major AbbVie’s Tepkinly (epcoritamab) in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma, widening the bispecific antibody’s European label into an earlier treatment setting 7 July 2026
Biotechnology
Taiwan-based PharmaEssentia yesterday announced that its wholly owned subsidiary, FORUS Therapeutics, has received a Notice of Compliance (NOC) from Health Canada, authorizing the use of Besremi (ropeginterferon alfa-2b) for the treatment of adults diagnosed with polycythemia vera (PV). 7 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has issued a warning letter to Genzyme Ireland, a Sanofi subsidiary, citing significant manufacturing violations at its Waterford biologics plant following an inspection in January. 6 July 2026
Biotechnology
In last week’s news, US biotech Replimune’s resubmitted biologicals license application (BLA) for RP1 (vusolimogene oderparepvec) was accepted by the Food and Drug Administration. On the M&A front, Zymeworks announced plans to acquire Theravance Biopharma and its key product Yupelri for COPD. French drugmaker Ipsen revealed plans to buy Kartos Therapeutics for an upfront $450 million, gaining rights to the latter’s navtemadlin. Ipsen then went to bid up to $1.75 billion for Memo Therapeutics and potravitug. Also, BioCrsyt Pharma revealed plans to wind down its internal discovery programs. 5 July 2026
Biotechnology
The US Food and Drug Administration has expanded approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) to patients aged two years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT). 2 July 2026
Biotechnology
Japanese drugmaker Kyowa Kirin’s US subsidiary has announced positive results from PROSPER, a real-world observational study of mogamulizumab, marketed as Poteligeo, in adults with mycosis fungoides (MF) or Sézary syndrome (SS). 1 July 2026
Biotechnology
Finnish clinical-stage biotech Aplagon has appointed pharmaceutical industry veteran Carl Lindgren as chair of its board of directors as the company prepares to advance its lead thrombo-inflammatory therapy into later-stage development. 30 June 2026
Biotechnology
India’s Dr Reddy’s Laboratories has received a fresh Form 483 from the US Food and Drug Administration, keeping regulatory scrutiny fixed on one of its biologics manufacturing sites just as the company pushes deeper into higher-value generics. 29 June 2026
Biotechnology
French drugmaker Ipsen today announced it has entered into a definitive merger agreement to acquire US cancer focused biotech Kartos Therapeutics. 29 June 2026
Biotechnology
M&A was again a big feature in last week's news, with AbbVie’s acquisition of Apogee Therapeutics, along with its atopic dermatology candidate zumilokibart, for $10.9 billion, and Germany’s Merck KGaA bid for US biotech Bio Techne for $11.3 billion in cash. US pharma giant Pfizer announced disappointing research findings, with its sigvotatug vedotin missing Phase III goals in lung cancer. The US Food and Drug Administration approved Ionis Pharma’s Tryngolza for severe hypertriglyceridemia. 28 June 2026
Pharmaceutical
The European Commission has expanded the marketing authorization for Otsuka Pharmaceutical Europe's Inaqovi (decitabine and cedazuridine), approving its use in combination with venetoclax for adults with newly diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. 26 June 2026
Pharmaceutical
Privately-held Italian drugmaker Menarini and Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, announced new data related to the pivotal Phase III SENTRY trial at The European Hematology Association (EHA) 2026 Congress. 26 June 2026
Biotechnology
US biotech Ionis Pharmaceuticals yesterday announced that the US Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500mg/dL). 25 June 2026
Pharmaceutical
Russian biopharmaceutical company Nanolek will launch armocibart, a hemophilia drug that was developed by Chinese company Suzhou Alphamab, in Russia and several other countries, reports The Pharma Letter’s local correspondent. 24 June 2026
Biotechnology
Dutch biotech uniQure, which is advancing transformative therapies for patients with severe medical needs, late Monday announced that it has commenced a $150 million underwritten public offering.
. 23 June 2026
Biotechnology
New PIONEER study data suggest that Ayvakit/Ayvakyt (avapritinib), from Blueprint Medicines—now part of French pharma major Sanofi—may improve day-to-day functioning and emotional well-being in patients with indolent systemic mastocytosis (ISM). 22 June 2026
Biotechnology
US cell therapy biotech Legend Biotech announced the pricing of an underwritten public offering of 7,700,000 American Depositary Shares (ADSs), each representing two ordinary shares of the Company, at a public offering price of $29.35 per ADS. 20 June 2026
Biotechnology
French pharma major Sanofi has secured approval in Japan for a subcutaneous formulation of Sarclisa (isatuximab) for multiple myeloma, marking the product’s second global approval after the European Union. 19 June 2026
Pharmaceutical
US biopharma company Veradermics last week reported encouraging top-line Phase II/III results for its hair loss treatment VDPHL01. On the M&A front, Eli Lilly announced it is to acquire Ajax Therapeutics for up to $2.3 billion along with its hematology candidate AJ1-110915. Also, Chiesi announced a takeover of USA-based KalVista Pharma and its Ekterly to expand its rare diseases portfolio. US biotech AnaptysBio won a favorable court ruling in its dispute with GSK/Tesaro over cancer drug Jemperli. 3 May 2026
Biotechnology
Hemab Therapeutics Holdings, a Phase III-ready biotech developing blood coagulation disorder treatments, has announced terms for its initial public offering (IPO). 1 May 2026
Pharmaceutical
US pharma major Eli Lilly delivered a standout first quarter of 2026, with financial results comfortably exceeding market expectations. 30 April 2026
Pharmaceutical
US pharma major Bristol Myers Squibb has reported better-than-expected financial results for the first quarter of 2026, with revenues rising 3% year-on-year to $11.49 billion, ahead of analyst forecasts of around $10.9 billion. 30 April 2026
Biotechnology
US pharma giant Pfizer has announced positive topline results from the Phase III MagnetisMM-5 study of Elrexfio (elranatamab) as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment. 30 April 2026
Biotechnology
The New England Journal of Medicine (NEJM) has published 26-week results from the Phase III FRONTIER2 trial evaluating the efficacy and safety of once-monthly and once-weekly Mim8 (denecimig) in adults and adolescents 12 years of age and older with hemophilia A (congenital Factor VIII (FVIII) deficiency), with or without FVIII inhibitors. Investigational denecimig is a bispecific antibody Factor VIIIa (FVIIIa) mimetic, designed for routine prophylaxis to help the body form blood clots. 30 April 2026
Biotechnology
Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for sovleplenib for the treatment of adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) who have had an insufficient response to at least one previous glucocorticoid treatment has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). 29 April 2026
Biotechnology
Gilead Sciences and its Kite Oncology subsidiary have announced that the European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved chimeric antigen receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). 28 April 2026
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, reported first-quarter revenue in line with expectations, while adjusted operating profit (EBITA) exceeded analyst forecasts. 28 April 2026
Biotechnology
US pharma major Eli Lilly is continuing its M&A spending spree, today announcing a definitive agreement to acquire Ajax Therapeutics, a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs). 27 April 2026
Pharmaceutical
Among significant news last week, Denmark’s Novo Nordisk presented positive results for its sickle cell disease candidate etavopivat. Eli Lilly revealed an up to $7 billion deal to acquire Kelonia Therapeutics and its gene therapy KLN-1010. The US Centers for Medicaid and Medicare Services (CMS) has extended the GLP-1 Bridge program for obesity medicines as insurers hold back. US biopharma Grace Therapeutics suffered a setback as the US Food and Drug Administration (FDA) issued a complete response letter (CRL) on the company’s new drug application (NDA) for GTx-104, which is being developed for aneurysmal subarachnoid hemorrhage (aSAH). 26 April 2026
Pharmaceutical
US biopharma Grace Therapeutics has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for GTx-104, sending the company’s shares down by 45% in Thursday's trading. 24 April 2026
Pharmaceutical
In the first three months of 2026, Swiss pharma giant Roche sales were up6% at constant exchange rates (CER), down 5% when reported in Swiss francs, to.7 billion francs ($18.7 billion) due to strong demand for pharmaceutical products and diagnostic solutions. 23 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
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
Danish pharma major Novo Nordisk today announced the top-line results from HIBISCUS, a pivotal Phase III trial of once-daily oral etavopivat in adults and adolescents with sickle cell disease (SCD). 20 April 2026
Pharmaceutical
Spanish plasma-derived medicines company Grifols announced that it has successfully completed the refinancing of its 2027 debt maturities through a new credit agreement structured as a Term Loan B (TLB), alongside a revolving credit facility. 17 April 2026
Biotechnology
Oxford, UK-based Alethio Therapeutics, a biopharmaceutical company developing novel treatments for myeloproliferative neoplasms (MPN), today announced the unveiling of ATX 011, a first in class, mutation agnostic antibody with potential to disrupt the $2 billion essential thrombocythemia (ET) market. 16 April 2026
Biotechnology
Eli Lilly has announced positive top-line results from the Phase III BRUIN CLL-322 trial. 14 April 2026
Pharmaceutical
Today, AstraZeneca announced that Lokelma (sodium zirconium cyclosilicate; SZC) has received a draft recommendation by the UK’s National Institute for Health and Care Excellence (NICE), broadening access for the treatment of hyperkalemia. 13 April 2026
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