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Takeda wins new EC approval for Adcetris

The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025

FDA clears Bayer’s Nubeqa in earlier-stage prostate cancer

The American medicines regulator has approved Bayer’s Nubeqa (darolutamide) for broader use in patients with metastatic castration-sensitive prostate cancer (mCSPC), marking a step forward for the drugmakeFood and Drug Administraton,r’s prostate cancer franchise. 4 June 2025

SFL’s Aumseqa approved in UK for NSCLC

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib) for adults with non-small cell lung cancer (NSCLC). 3 June 2025

MaaT closes in on Europe’s first microbiota therapeutic approval

Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025

Mabwell wins China nod for first innovative biologic, eyes Hong Kong listing

Shanghai-based Mabwell Bioscience has secured approval from the Chinese regulator for its first locally developed novel biologic, marking a pivotal moment in the company's ambitions to expand its oncology pipeline and strengthen its commercial presence in Asia and beyond. 3 June 2025

Opdivo SC wins EC approval

US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025

IGBA welcomes ICH new topic for harmonization on biosimilars development

In a website posting, the International Generic and Biosimilar medicines Association (IGBA) has commended the General Assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonization of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs." 2 June 2025

The week in pharma: action, reaction and insight – week to May 30

Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025

mNEXSPIKE becomes Moderna's third FDA-approved product

The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025

Zymeworks’ zanidatamab approved in China

Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025

In the era of RFK Jr, pharma must turn to education in advertising

A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 2025

EMA pressed for clearer guidance on decentralized trials

Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025

Alcon gains FDA approval of Tryptyr in DED

Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025

Stealth Bio confident, despite earlier FDA delays for elamipretide

The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025

EC approval for BMS’ subcutaneous Opdivo

The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025

Daiichi and Merck pull patritumab deruxtecan BLA

Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025

FDA refuses to file Savara BLA for Molbreevi

Texas, USA-based clinical-stage biopharma Savara on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94. 28 May 2025

CDC drops COVID-19 jab from routine vaccine schedules

In a policy shift that breaks with the previous administration's broad vaccination campaign, US health authorities have removed the COVID-19 vaccine from the routine immunization schedule for healthy children and healthy pregnant women. 28 May 2025

FDA pauses Rocket’s Phase II trial of RP-A501 for Danon disease

US late-stage biotech Rocket Pharmaceuticals saw its shares plummet as much as 64% to $2.25 in pre-market activity today, after it announced an update related to a trial of RP-A501, its investigational gene therapy for Danon disease, which resulted in a patient death. 27 May 2025

Biocon Biologics receives MHRA approval for Yesintek

Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025

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The week in pharma: action, reaction and insight – week to July 25

Last week, a US Food and Drug Administration (FDA) advisory committee (AdCom) voted against approval of Danish drugmaker Lundbeck and Japan-based Otsuka’s Rexulti for post-traumatic stress disorder. France’s Sanofi announced it is expanding its respiratory vaccines pipeline with an up to $1.6 billion acquisition of UK biotech Vicebio. French biotech Abivax released new Phase III data on its investigational ulcerative colitis candidate obefazimod that saw its shares nearly quadruple. Also of note was the latest setback for Sarepta’s Duchenne muscular dystrophy drug Elevidys, when the European Medicines human health committee, the CHMP, declined partner Roche’s accelerated approval of the drug. 27 July 2025

FDA delays review of Bayer’s elinzanetant NDA

The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug Application (NDA) for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) due to menopause. 26 July 2025

Another negative development for Elevidys

As if there had not been enough negative news regarding Elevidys (delandistrogene moxeparvovec) this month, there was more today from the European regulator. 25 July 2025

New medicines recommended for approval by EMA’s CHMP

The European Medicines’ (EMA) human medicines committee (CHMP) has recommended seven novel medicines for approval at its July 2025 meeting. 25 July 2025

Ipsen’s Cabometyx secures EC nod for neuroendocrine tumors

French drugmaker Ipsen announced that the European Commission (EC) has approved Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. 25 July 2025

Trump presses Supreme Court to allow NIH to cancel $783 million in grants

The Trump administration has asked the US Supreme Court to allow the National Institutes of Health (NIH) to resume canceling hundreds of research grants supporting work on health equity, racial disparities, and other diversity-related public health initiatives. 25 July 2025

Unlike FDA, EC backs re-approval of GSK’s Blenrep

In an import contrast to events in the USA, UK pharma major GSK late Thursday announced the approval of Blenrep (belantamab mafodotin) by the European Commission. 25 July 2025

Sanofi’s Sarclisa gains new approval in the EU

Following the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on June 19, 2025, the European Commission has approved French pharma major Sanofi's (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. 25 July 2025

Undervalued and understocked: are generics in crisis?

Hospitals are rationing cancer treatments. Pharmacies are scrambling to fill routine antibiotic prescriptions. And across the USA, patients are facing growing delays, substitutions, or outright denials of essential medicines, not because the drugs don’t exist, but because the supply chains behind them have buckled. 24 July 2025

MHRA approves AbbVie’s Elahere

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved US pharma major AbbVie’s Elahere (mirvetuximab soravtansine) to treat adults with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 24 July 2025

FDA green light for LEO’s Anzupgo

Privately-held Danish dermatology specialist LEO Pharma today revealed that the US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 24 July 2025

Roche halts ex-US shipments of Elevidys

Swiss pharma giant Roche has paused shipments of the gene therapy Elevidys (delandistrogene moxeparvovec) for new orders in certain countries outside the USA. 24 July 2025

Avidity granted FDA Breakthrough status for DMD therapy

US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota, formerly known as AOC 1044), the company’s investigational therapy for the treatment of people with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44). 24 July 2025

Blenrep saga drags on as PDUFA date put back

The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for GSK’s Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 24 July 2025

J&J blockbusters bag new hematology approvals

US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the European Commission (EC) has approved a new indication and an indication extension for Darzalex (daratumumab) and Imbruvica (ibrutinib), respectively. 23 July 2025

Leriglitazone MMA validated by EMA

Privately-held Spanish CNS specialist Minoryx Therapeutics and Germany’s Neuraxpharm Group today announced that the marketing authorization application (MAA) for Minoryx’ lead candidate Nezglyal (leriglitazone) has been submitted to the European Medicines Agency (EMA) for the treatment of pediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). 23 July 2025

EC approves Roche’s Itovebi

The European Commission has approved Swiss pharma giant Roche’s Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. 23 July 2025

UK first to allow bedside production of personalized therapies

Patients in the UK will now be able to access advanced, personalized treatments prepared at the hospital or even in mobile units near their homes, thanks to a world-first regulatory shift. New legislation introduced by the country’s drug regulator allows hospitals and care centers to produce small or individual batches of cutting-edge therapies at the point of care. 23 July 2025

ImCheck doubles up on orphan designations for ICT01 in AML

French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025

Replimune rocked by CRL for lead candidate

Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025

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