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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

Eisai’s anti-insomnia drug Dayvigo approved in China

Japanese drugmaker Eisai today announced that the in-house-discovered and developed orexin receptor antagonist Dayvigo (lemborexant) has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025. 27 May 2025

FDA accepts sibeprenlimab BLA for priority review

Japanese drugmaker Otsuka Pharmaceutical today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). 26 May 2025

Added FDA approval for Celltrion’s Yuflyma

The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025

FDA AdCom recommendations on COVID-19 vaccines

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22 to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the USA beginning in the fall of 2025. 26 May 2025

The week in pharma: action, reaction and insight – week to May 23

Last week saw Novavax receive full approval from the US Food and Drug Administration (FDA) for its COVID-19 vaccine, but with post-market requirements. Swiss gene-editing company CRISPR Therapeutics linked up with Sirius Therapeutics to develop siRNA therapeutics, notably the latter’s SRSD107 in cardiovascular indications. The FDA last week announced a new executive order aiming to provide a pathway for prescription drugs from Canada, Also of note, Gilead Sciences released positive results for its Trodelvy ASCENT-03 study in metastatic triple negative breast cancer (mTNBC). 25 May 2025

May batch of novel medicines recommended for approval by CHMP

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025

MHRA approves Akantior to treat acanthamoeba keratitis

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today revealed it has approved Akantior (polihexanide) to treat acanthamoeba keratitis (AK). 23 May 2025

Relief value doubles on FDA designation

Swiss biopharma Relief Therapeutics closed Thursday’s trading 50% higher. 23 May 2025

Nucala approved by FDA for use in adults with COPD

UK pharma major GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 23 May 2025

FDA nod for Roche’s Susvimo for diabetic retinopathy

The US Food and Drug Administration (FDA) has approved Roche’s(ROG: SIX) Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the USA and more than 100 million people globally. 23 May 2025

FDA takes steps to enhance state medicines importation

The US Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. 22 May 2025

UroGen tanks as FDA panel vote goes against UGN-102

USA-based UroGen Pharma, a biotech developing and commercializing innovative solutions that treat urothelial and specialty cancers, closed 45% lower Wednesday. 22 May 2025

FDA officials unwisely limit COVID-19 vaccine, says Public Citizen

The US Food and Drug Administration (FDA) is set to sharply restrict vaccine availability to millions of Americans without a persuasive justification based in science. 22 May 2025

Moderna opts to withdraw BLA for mRNA-1083

US biotech Moderna today announced that in consultation with the US Food and Drug Administration (FDA), the company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. 21 May 2025

COVID-19 vaccine manufacturers avoid new placebo comparison requirement

Earlier this month, the US Department of Health and Human Services (HHS) said it would require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 21 May 2025

vTv resumes Phase III oral T1D drug study

North Carolina, USA-based vTv Therapeutics has announced that screening has been reinitiated in the company’s CATT1 Phase III trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes (T1D). 21 May 2025

FDA advisers back Darzalex, raise concerns over Columvi trial

A panel of experts convened by the US regulator has given a cautious nod to Johnson & Johnson’s Darzalex Faspro (daratumumab/hyaluronidase-fihj) for some multiple myeloma patients. 21 May 2025

GSK’s Blenrep combination approved by Japan MHLW

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved UK pharma major GSK’s Blenrep (belantamab mafodotin) combination for the treatment of adults with relapsed or refractory multiple myeloma. 20 May 2025

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Slovakia: Information portal on new drugs and indications

The information portal on the entry of new medicines and indications shows the number of new medicines and indications (expanding the possibilities of treating various types of diseases with given medicines) included in the standard system of reimbursement from public health insurance, the Slovak pharma trade group AIFP noted in a website posting. 28 July 2025

Imfinzi granted Breakthrough status for gastric and GEJ cancers in USA

UK pharma major AstraZeneca this morning revealed that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the USA for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. 28 July 2025

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

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