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NICE backs Darzalex-based quadruplet for newly-diagnosed myeloma, J&J's second blood cancer win in a week

The UK's National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Johnson & Johnson's Darzalex (daratumumab) with bortezomib, lenalidomide and dexamethasone (D-VRd), followed by daratumumab-lenalidomide maintenance, for previously untreated multiple myeloma in transplant-eligible adults. 10 September 2026

BMS' GPRC5D CAR T therapy hits response goals in heavily pretreated myeloma

Bristol Myers Squibb, the US pharma major, has reported positive topline Phase II results for arlocabtagene autoleucel (arlo-cel; BMS-986393), an investigational GPRC5D-directed CAR T cell therapy, in patients with relapsed and refractory multiple myeloma who had already failed four drug classes. 9 September 2026

Cytospire names Sumeet Ambarkhane as CMO

UK biotech Cytospire Therapeutics, which is developing differentiated multispecific immune cell engager antibodies, today announces the appointment of Dr Sumeet Ambarkhane as chief medical officer (CMO). 8 September 2026

AbbVie's etentamig hits dual primary endpoints in Phase III relapsed/refractory multiple myeloma trial

US pharma major AbbVie announced positive top-line results from the Phase III CERVINO trial evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, against investigator's choice of standard available therapies (SAT) in triple-class exposed relapsed/refractory multiple myeloma (RRMM). 3 September 2026

Priothera appoints Dr Nigel Clark as CBO

Priothera, a late-stage clinical biopharmaceutical company, has announced the appointment of Dr Nigel Clark, as chief business officer (CBO). 3 September 2026

Treeline Biosciences enters clinical trial collaboration with Roche

Privately-held US biotech Treeline Biosciences today announced a clinical trial collaboration and supply agreement with Swiss giant Roche to evaluate TLN-121, Treeline's BCL6 degrader. 2 September 2026

Beam Therapeutics appoints Eric Foster as CCO

Beam Therapeutics, a Cambridge, Massachusetts-based biotech developing precision genetic medicines through base editing, announced Tuesday the appointment of Eric Foster as chief commercial officer (CCO). 1 September 2026

FDA approves Besremi, a treatment for essential thrombocythemia

The US Food and Drug Administration has approved Besremi (ropeginterferon alfa-2b-njft) injection for the treatment of adults with essential thrombocythemia, from Taiwan-based PharmaEssentia. 1 September 2026

Russia experiencing shortage of hemophilia B drugs

Russia is experiencing a shortage of drugs for patients with hemophilia B. Currently the most complex situation is observed in the case of both plasma-derived and recombinant coagulation factor IX which is the main replacement therapy for these patients, reports The Pharma Letter’s local correspondent. 1 September 2026

Takeda receives US FDA approval of Mimrylo

Japan’s largest drugmaker Takeda announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. 29 August 2026

Positive Ph III Tezspire data eosinophilic esophagitis

Positive high-level results from the Phase III CROSSING trial in patients with eosinophilic esophagitis (EoE) showed that AstraZeneca and Amgen’s Tezspire (tezepelumab) demonstrated statistically-significant and clinically-meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested. 27 August 2026

J&J's Imaavy wins first-ever US nod for rare blood disorder

US pharma major Johnson & Johnson has landed a second US approval for Imaavy (nipocalimab), with the Food and Drug Administration (FDA) clearing the FcRn blocker on Monday for warm autoimmune hemolytic anemia, or wAIHA, in adults and children aged 12 and over who are taking, or have previously taken, corticosteroids. 25 August 2026

Partnership to expand access to Brukinsa in low- and middle-income countries

Sino-American oncology-focused biotech BeOne Medicines, together with the BeOne Care Foundation, a non-profit charitable foundation, and The Max Foundation, a global health non-profit organization, have announced the renewal of their partnership through 2028 to expand access to Brukinsa (zanubrutinib) for the treatment of chronic lymphocytic leukemia (CLL) in low- and middle-income countries, with the program projected to support approximately 1,000 patients cumulatively. 24 August 2026

Xspray's Dasynoc blocked for a fourth time as FDA points to contract manufacturer

Swedish specialty pharma company Xspray Pharma has been turned away by the US Food and Drug Administration (FDA) for a fourth time, receiving a Complete Response Letter (CRL) for leukemia candidate Dasynoc on August 19, less than a week before a scheduled decision date of August 25. 24 August 2026

EC approves J&J's Tecvayli plus daratumumab combination for earlier-line multiple myeloma

Johnson & Johnson has announced that the European Commission (EC) has approved an indication extension for Tecvayli (teclistamab) in combination with daratumumab for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy, introducing the option as early as second line. 21 August 2026

Merck and Moderna announce Phase III INTerpath-001 trial of intismeran combo

US pharma companies Merck, known as MSD outside of the USA and Canada, and Moderna today announced positive top-line results from the Phase III INTerpath-001 trial. 19 August 2026

Biogen's felzartamab wins first global approval, cleared in China for multiple myeloma

US biotech Biogen and its Chinese partner TJ Biopharma announced that felzartamab for injection - branded Jingfei in China - has been approved by China's National Medical Products Administration (NMPA) for use with lenalidomide and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy. 17 August 2026

FDA accelerated approval for BMS’ Zenbexus

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. 14 August 2026

Silence Therapeutics' siRNA hits the mark in polycythemia vera

London-based biotech firm Silence Therapeutics said on Monday that lead candidate divesiran met the primary endpoint of the Phase II SANRECO trial in polycythemia vera (PV), a rare blood cancer in which the bone marrow overproduces red blood cells. Shares rose sharply on the news, touching a 52-week high. 11 August 2026

Sobi licenses lacutamab from Innate Pharma

French rare diseases company Innate Pharma (and Swedish Orphan Biovitrum (Sobi) have entered a strategic partnership to enable initiation of the TELLOMAK-3 confirmatory Phase III study in cutaneous T-cell lymphoma (CTCL). 10 August 2026

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Genmab selects Anthropic for AI-powered programs

Danish biotech Genmab has partnered with artificial intelligence company Anthropic to deploy agentic AI tools across parts of its clinical development operations. The collaboration centers on custom Claude-powered systems designed to support data processing, analysis, and document generation as programs move toward regulatory milestones. 8 January 2026

Positive Phase III trial of Hutchmed’s sovleplenib

Chinese biopharma Hutchmed today announces that the Phase III registration part of the ESLIM-02 clinical trial of sovleplenib, a novel spleen tyrosine kinase (Syk) inhibitor, in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China has met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment. 7 January 2026

J&J files for expanded Tecvayli–Darzalex use in myeloma

US healthcare major Johnson & Johnson has submitted a Type II variation to the European Medicines Agency seeking to extend use of Tecvayli (teclistamab) in combination with Darzalex subcutaneous (daratumumab) for adults with relapsed or refractory multiple myeloma after at least one prior therapy. 7 January 2026

$840 million Dark Blue buy hands Amgen AML drug

US biotech major Amgen has announced its acquisition of privately-held UK firm Dark Blue Therapeutics, a biotech advancing first-in-class, small molecule-targeted protein degraders for oncology, in a transaction valued at up to $840 million. 6 January 2026

Ribo launches Hong Kong IPO with first-in-class siRNA clotting drug at core

Chinese RNA drug developer Ribo has launched a Hong Kong IPO, positioning its lead siRNA candidate for thrombotic diseases as a flagship asset as investors gain rare access to China’s small nucleic acid drug sector. 5 January 2026

The week in pharma: action, reaction and insight – week to January 2, 2026

In a slow news last week a mixed batch of clinical trials results featured. First, US biotech Ultragenyx announced disappointing Phase III results for its Osteogenesis Imperfecta (OI) candidate setrusumab, under development with Mereo BioPharm. Then InflaRx presented a new analysis of vilobelimab for pyoderma gangrenosum, and Pfizer disclosed a death in a long term Hympavzi study after thrombotic stroke. Also of note, after previous setbacks, the US Food and Drug Administration (FDA) granted approval for Vanda Pharmaceuticals’ motion sickness drug Nereus (tradipitant). 4 January 2026

Pfizer discloses death in long-term Hympavzi study after thrombotic stroke

US pharma major Pfizer has reported the death of a participant enrolled in a long-term extension study of its haemophilia therapy Hympavzi (marstacimab), after a thrombotic stroke following minor surgery. 2 January 2026

The week in pharma: action, reaction and insight – week to December 26, 2025

M&A news last week featured French pharma major Sanofi announcing an agreement to acquire US vaccine maker Dynavax Technologies for around $2.2 billion, as well as a setback with its multiple sclerosis drug tolebrutinib. On the regulatory front, USA-based Omeros revealed that its Yartemlea had received Food and Administration (FDA) approval for TA-TMA. Also, US drugmaker Agios Pharmaceuticals won FDA approval for its Aqvesme as a first oral anemia treatment across thalassaemia. 28 December 2025

Omeros rockets as FDA approves Yartemlea

Seattle, USA-based biotech Omeros Corp saw its shares leap 75.5% to $15.36 by close of trading Wednesday, as it revealed that the US Food and Drug Administration (FDA) has approved its Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). 26 December 2025

First oral anemia treatment across thalassaemia types approved in USA

US rare disease specialist Agios Pharmaceuticals has won approval for Aqvesme (mitapivat) to treat anemia in adults with alpha- or beta-thalassaemia, covering both non-transfusion-dependent and transfusion-dependent forms. The oral therapy is the first authorised for this broad patient population. 24 December 2025

FDA approves Grifols’ Fesilty for rare bleeding disorder

Barcelona, Spain-based Grifols announced that its fibrinogen concentrate, Fesilty (fibrinogen, human-chmt), has been approved by the US Food and Drug Administration (FDA) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. 22 December 2025

CSL’s innovative approach ensuring Hemgenix delivers for patients

CSL presented new HOPE-B Phase III data confirming the five-year durability of Hemgenix (etranacogene dezaparvovec), the only gene therapy for haemophilia B, at the American Society of Hematology (ASH) Annual Meeting earlier this month. 21 December 2025

Allosteric therapeutics co Atavistik Bio raises $120 million Series B

US precision allosteric therapeutics company Atavistik Bio has raised a $120 million Series B financing. 19 December 2025

Priority review for Opdivo and chemo in cHL

US pharma major Bristol Myers Squibb has announced progress for its multi-indication cancer drug Opdivo (nivolumab) in another oncology setting. 11 December 2025

Sanofi wins China approval for Qfitlia and Cablivi

Chinese regulator the National Medical Products Administration (NMPA) has approved two innovative medicines for rare hematologic diseases: Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura, both from French pharma major Sanofi. 11 December 2025

Tecvayli and Darzalex combination delivers in RRMM

US healthcare giant Johnson & Johnson has announced new data from the investigational Phase III MajesTEC-3 study showing the potential of Tecvayli (teclistamab) plus Darzalex subcutaneous (daratumumab SC) formulation as early as second line for patients with relapsed/refractory multiple myeloma (RRMM). 10 December 2025

‘Revolutionary’ approval for Gamida Cell’s Omisirge

Florida-based cell therapy company Gamida Cell has won US approval for Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). 9 December 2025

FDA column calls for evidence-based trial design for CAR-T therapies in oncology

Vinay Prasad, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), has taken the position that randomized controlled trials (RCTs) should be the standard moving forward for CAR-T cell therapies in cancer. 9 December 2025

Prospects for Priligy as first mover CAR-T therapy for lymphoblastic leukemia in China

China is making significant strides in CAR-T innovation. Recently, Chongqing Precision Biotech received approval for Priligy (priscabtagene autoleucel) to treat pediatric and adolescent patients aged 3 to 21 years with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). 9 December 2025

Lunsumio data shows potential in earlier lymphoma treatment lines

Roche has unveiled a fresh wave of data for Lunsumio (mosunetuzumab), underscoring the Swiss pharma major’s ambition to move its CD20xCD3 bispecific earlier in follicular and large B-cell lymphomas. 9 December 2025

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