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Pierre Fabre gains EU first-line approval for Braftovi regimen

French drugmaker Pierre Fabre has won European Commission approval for Braftovi (encorafenib) in combination with cetuximab and FOLFOX as a first-line treatment for adults with BRAF V600E-mutant metastatic colorectal cancer. 23 June 2026

Regenxbio rises after FDA clears path for Hunter syndrome gene therapy resubmission

Shares in US gene therapy developer Regenxbio closed 16.3% higher Monday after the company said it had reached alignment with the US Food and Drug Administration (FDA) on a route to resubmit its biologics license application (BLA) for Navsunli (clemidsogene lanparvovec-sngl), an investigational treatment for mucopolysaccharidosis type II (MPS II), or Hunter syndrome. 23 June 2026

CARsgen scores a first with NMPA approval of satri-cel

China-based biotech CARsgen Therapeutics’ shares rose 6.8% to HK$16.82, after it announced that the National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of satricabtagene autoleucel (satri-cel), the proprietary autologous humanized Claudin18.2 CAR T-cell therapy product. 23 June 2026

First disease modifying treatment for type 1 diabetes backed by UK’s NICE

The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending a new drug – teplizumab from French pharma major Sanofi - that delays the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. 23 June 2026

Sanofi announces approvals for Wayrilz and Cenrifki

The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing and manufacturing authorization to French pharma major Sanofi’s Wayrilz (rilzabrutinib), a novel oral reversible Bruton’s tyrosine kinase inhibitor (BTKi). 23 June 2026

Wegovy SC approved in Japan for MASH

Danish pharma major Novo Nordisk has received a partial change approval of the manufacturing and marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Wegovy (semaglutide) subcutaneous, its once-weekly GLP-1 receptor agonist co-promoted with local drugmaker Sumitomo Pharma. 22 June 2026

TGA posts new guidance on advertising restrictions for Rx meds

Australia’s Therapeutic Goods Administration (TGA) has published new guidance on advertising restrictions for prescription medicines. This is to help individuals and businesses comply with Australia’s regulatory requirements. 22 June 2026

Regulatory round-up: 22 June 2026

Regulators put safety and compliance in the foreground over the past week, with updates stretching from new prescribing guidance in the USA to product safety action in Asia-Pacific and Latin America. The US Food and Drug Administration approved Utebzi for complicated urinary tract infections, while Australia’s Therapeutic Goods Administration sharpened its public messaging on unapproved peptide products and prescription medicine advertising. 22 June 2026

pharma.be lauds strong pharma sector, but warns of dark clouds

This year, Belgian trade group pharma.be celebrates its 60th anniversary. Throughout all these decades, biopharmaceutical companies have contributed to cutting-edge scientific research through partnerships with universities and research institutions, it noted. 22 June 2026

The week in pharma: action, reaction and insight – week to June 19, 2026

Among notable news last week, The US Centers for Medicare and Medicaid Services (CMS) announced a permanent framework for Medicaid price negotiations. US biotech Neumora said it is dropping development of its navacaprant after it missed key and secondary endpoints in a Phase III study, while Dutch biotech uniCure revealed that the US Food and Drug Administration (FDA) has accepted its filing for Huntington’s candidate AMT-130. Also, US biotech Biogen announced it is acquiring RayThera for up to $1 billion to expand its immunology pipeline. 21 June 2026

FDA AdCom unanimously backs Moderna’s mFlusiva

Moderna’s shares closed up 3.5% at $63.96 after the announcement on Thursday of a positive vote by a US Food and Drug Administration's (FDA) advisory committee (AdCom). 19 June 2026

Batch of regulatory news from Chugai

Japanese drugmaker Chugai today announced three regulatory developments for the company, which is majority-owned by Swiss pharma giant Roche. 19 June 2026

Sanofi wins Japan approval for subcutaneous Sarclisa in multiple myeloma

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

Shionogi wins added approval for Xocova in Japan

Japanese pharma major Shionogi announced that it received supplemental approval in Japan today for the pediatric dosage and administration of Xocova (ensitrelvir fumaric acid). 19 June 2026

Teva submits NDA for ecopipam in USA

Israel-headquartered Teva Pharmaceutical Industries has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ecopipam, a first-in-class investigational therapy for the treatment of pediatric Tourette syndrome. 19 June 2026

FDA expands Merck’s Capvaxive label for at-risk children and adolescents

Pharma major Merck & Co has won US approval for an expanded indication for Capvaxive (pneumococcal 21-valent conjugate vaccine), covering children and adolescents aged two to 17 years who are at increased risk of pneumococcal disease. 18 June 2026

Sanofi’s Sarclisa SC wins MHRA backing

The UK Medicines and Healthcare products Regulatory agency (MHRA) has granted marketing authorization for Sanofi’s Sarclisa (isatuximab) for subcutaneous (SC) use in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications approved for the intravenous (IV) formulation. 18 June 2026

FDA drug approvals rebound above decade average in 2025, says GlobalData

The US Food and Drug Administration (FDA) approved 131 drugs across new drug application (NDA), biologics license application (BLA), and biosimilar pathways in 2025, a 4.8% rise from the previous year, according to a new report from data and analytics firm GlobalData. 18 June 2026

FDA accepts Roche’s sBLA for Lunsumio and Polivy combo

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin), Swiss pharma giant Roche announced today. 18 June 2026

First generic Xofluza clears US FDA ahead of flu season

The US Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals’ tablets ahead of the 2026-2027 influenza season. 18 June 2026

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US House markup of expedited Access to Biosimilars Act welcomed

The US Biosimilars Council and the Association for Accessible Medicines (AAM) have lauded legislative progress as the House Energy and Commerce Committee marked up and voted to approve the Expedited Access to Biosimilars Act and the Biosimilars Red Tape Elimination Act. 22 July 2026

EC expands Crysvita approval to infants with rare phosphate disorder

The European Commission has approved an expanded indication for Japan-based pharma company Kyowa Kirin’s Crysvita (burosumab), allowing the medicine to be used in infants from one month to under one year of age with X-linked hypophosphataemia (XLH). 21 July 2026

MHRA approves Chiesi's carbon minimal inhaler - a world first

Privately-held Italian drugmaker Chiesi today announced UK Medicines and Healthcare products Regulatory Agency (MHRA) approval of Clenil Modulite (beclometasone; 100mcg and 200mcg) formulated with a next-generation, non-PFAS, low GWP propellant. 21 July 2026

FDA accepts Dyne Duchenne BLA, grants Priority Review

US biotech Dyne Therapeutics has moved closer to a possible first approval after the US Food and Drug Administration accepted its biologics license application for zeleciment rostudirsen, or z-rostudirsen, in Duchenne muscular dystrophy. 20 July 2026

FDA accepts Shionogi’s sNDA for Fetroja

The US Food and Drug Administration (FDA) has accepted Japanese pharma major Shionogi’s supplemental New Drug Application (sNDA) for Fetroja (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Gram-negative microorganisms. 20 July 2026

Almirall seeks broader EU approval for Ebglyss in younger children with atopic dermatitis

Spanish dermatology-focused Almirall is seeking to expand the European label for Ebglyss (lebrikizumab) in atopic dermatitis, after the European Medicines Agency (EMA) accepted its application for use in children and adolescents aged six months to under 18 years who weigh less than 40kg. 20 July 2026

Regulatory round-up: 20 July 2026

Medicines regulators in major international markets have issued a mix of approvals, safety communications, recalls, enforcement actions and procedural updates over the past week. 20 July 2026

The week in pharma: action, reaction and insight – week to July 17, 2026

Last week saw AstraZeneca sign an accord with China’s Dizal Pharmaceutical for rights to the latter’s lung cancer drug Zegfrovy. Biogen released new Phase II data its Alzheimer’s candidate diranersen that raised questions. Celcuity won US Food and Drug Administration (FDA) for its investigational breast cancer drug Revtorpyk and Merck & Co announced FDA approval for its oral PCK9 cholesterol drug Lipfendra. Eli Lilly revealed plans to acquire mental health biotech AtaiBeckley for an upfront $2.8 billion. 19 July 2026

GSK’s Amanda Peppercorn on bringing the first oral carbapenem to cUTI patients

The US Food and Drug Administration’s (FDA) approval of Utebzi (tebipenem pivoxil) gives physicians the first oral carbapenem option for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, who have limited or no alternative oral treatment options. 17 July 2026

Novartis’ Fabhalta wins FDA traditional approval

Swiss pharma giant Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. 17 July 2026

EU approval of Arrowhead’s Redemplo to expand FCS treatment options

Arrowhead Pharmaceuticals has recently announced that the European Commission has granted marketing authorization for Redemplo (plozasiran), an innovative apolipoprotein C III (apoC-III) inhibitor that is already approved in the USA for the treatment of adults with familial chylomicronemia syndrome (FCS). 17 July 2026

Swiss firm Swixx registers new drug for lymphoma in Russian market

The Russian Ministry of Health has officially registered a new drug for the treatment of lymphoma. The drug from Swiss company Swixx Biopharma, which is marketed under the Mindzhuvi, becomes the first drug containing tafasitamab on the Russian market. 16 July 2026

Merck & Co’s cholesterol cutting drug Lipfendra wins FDA approval

US pharma major Merck today revealed it has gained US Food and Drug Administration (FDA) approval for Lipfendra (enlicitide) tablets 20mg as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. 16 July 2026

EC approval of Novo Nordisk’s Wegovy pill

Danish pharma major Novo Nordisk late yesterday announced that the European Commission (EC) has granted marketing authorization for Wegovy pill (once-daily oral semaglutide 25 mg) for the treatment of adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. 16 July 2026

MHRA grants marketing authorization for Akeega

The UK’s Medicines and Healthcare products Regulatory agency (MHRA) has granted marketing authorization for Johnson & Johnson’s Akeega (niraparib and abiraterone acetate dual-action pill), with prednisone or prednisolone, in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic). 16 July 2026

Updated warnings for botulinum toxin products from MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is strengthening safety warnings for all botulinum toxin type A products, following reports of rare cases of botulism linked to their use. 15 July 2026

EMA and EISMEA boost cooperation to accelerate health innovations

The European Medicines Agency (EMA) and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). 15 July 2026

NICE backs Bayer’s Kerendia for heart failure with LVEF ≥40%

Bayer announced today that the UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Kerendia (finerenone), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of symptomatic chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40% in adults. 15 July 2026

FDA grants priority review to Genentech’s Gazyva sBLA in pMN

For the first time, a treatment specifically designed to address primary membranous nephropathy (pMN) is moving closer to US Food and Drug Administration (FDA) approval. 15 July 2026

Celcuity wins first FDA approval with Revtorpyk in advanced breast cancer

USA-based biotech Celcuity has won its first US Food and Drug Administration (FDA) approval, with the regulator clearing Revtorpyk (gedatolisib) for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one line of endocrine therapy in the metastatic setting. 15 July 2026

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