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Biotechnology
Swiss biotech Pharvaris has moved a step closer to the US market after the Food and Drug Administration (FDA) accepted its New Drug Application for deucrictibant immediate-release capsules as an on-demand treatment for hereditary angioedema (HAE) attacks. 6 July 2026
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Incyte’s Zynyz (retifanlimab) as the first treatment given to adults with advanced Merkel cell skin cancer that has spread or returned and cannot be cured with an operation or radiotherapy. 6 July 2026
Pharmaceutical
A new first of its kind glucagon-like peptide 1 (GLP-1) receptor agonist daily weight-loss pill is now available for eligible patients in the UK, expanding treatment options for obesity. 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
Pharmaceutical
Danish drugmaker Novo Nordisk has won conditional UK marketing authorization for Wegovy (semaglutide) in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis, extending the GLP-1 drug beyond weight management and cardiovascular risk reduction. 3 July 2026
Pharmaceutical
Russian pharmaceutical companies and global drugmakers operating in the local market have called on the national government to speed the process of entering new drugs in public procurements after their registration, reports The Pharma Letter’s local correspondent. 3 July 2026
Pharmaceutical
French rare disease specialist Advicenne has secured unlimited renewal of the UK marketing authorization for Sibnayal (potassium citrate/potassium bicarbonate), marking another regulatory milestone for its lead kidney disease therapy as the company also awaits a key US approval decision later this year. 2 July 2026
Pharmaceutical
Japanese drugmaker Eisai today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant. 2 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
Pharmaceutical
Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for Orpathys (savolitinib) has been granted conditional approval by the China National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. 2 July 2026
Biotechnology
Novartis today announced that the European Commission (EC) has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. 2 July 2026
Pharmaceutical
UK-based BioPhorum today announced the formation of the Synthetic Molecule Process Innovation Phorum, uniting an ecosystem of 20 leading organizations to urgently address the rapidly accelerating pace of innovation in the small molecule sector. 1 July 2026
Biotechnology
Privately-held US cell therapy company Orca Bio announced the US Food and Drug Administration (FDA) has approved Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T. 1 July 2026
Pharmaceutical
US Immuno-dermatology specialist Arcutis announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. 30 June 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has selected seven companies for the first cohort of its PreCheck Pilot Program, which is intended to give manufacturers earlier regulatory feedback on new pharmaceutical facilities. 30 June 2026
Biotechnology
Swiss pharma giant Roche today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of thyroid eye disease (TED). 30 June 2026
Biotechnology
Shares of US biotech Larimar Therapeutics closed down 16.5% at $3.06 yesterday, despite the company announcing the submission of the first module of its rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the accelerated approval of nomlabofusp. 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
Replimune has gained another chance to secure accelerated approval for its lead melanoma candidate RP1, after the US Food and Drug Administration accepted a resubmitted biologics license application. 29 June 2026
Biotechnology
The European Commission (EC) has approved UK pharma major AstraZeneca and Japanese drugmaker Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy for adults with unresectable or metastatic HER2-positive, immunohistochemistry (IHC) 3+, solid tumors who have received prior treatment and have no satisfactory treatment options. 29 June 2026
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
Eisai and Biogen have secured US approval for patients to begin treatment with an at-home version of their Alzheimer’s medicine Leqembi Iqlik (lecanemab-irmb), removing the need to start therapy through intravenous infusions. 14 July 2026
Pharmaceutical
Medicines regulators in several major markets have issued a mix of approvals, safety communications, supply notices, enforcement actions and procedural updates over the past week. 13 July 2026
Biotechnology
Elevar Therapeutics, a majority-owned subsidiary of South Korea's HLB , has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application seeking approval of rivoceranib in combination with AiRuiKa (camrelizumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma. 13 July 2026
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