Regulation
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Pharmaceutical
China’s National Medical Products Administration (NMPA) conducted its 2025 annual management review of the Quality Management System (QMS) for regulation of vaccine and drug Good Manufacturing Practice (GMP) compliance on June 30. 10 July 2026
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance rejecting routine National Health Service (NHS) use of Amgen’s Lumykras (sotorasib) for previously treated KRAS G12C-mutated advanced non-small-cell lung cancer. 10 July 2026
Generics
Hyderabad, India-based Natco Pharma shares gained nearly 3% after unveiling a $300 million investment plan in South Africa aimed at strengthening its footprint across new geographies. 10 July 2026
Biotechnology
The China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for Padcev (enfortumab vedotin) in combination with Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-containing chemotherapy. 9 July 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months, said Arcutis Biotherapeutics. 9 July 2026
Pharmaceutical
vGerman pharma and life science company Merck KGaA today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. 8 July 2026
Pharmaceutical
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (8 July 2026) approved Jascayd (nerandomilast) to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). 8 July 2026
Biotechnology
Since the US Food and Drug Administration (FDA) first awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017, activity in this space remained relatively modest until 2023. 8 July 2026
Pharmaceutical
German family-owned drugmaker Grünenthal today announced that its investigational compound tegacorat (GRM-01) received Orphan Drug and Rare Pediatric Disease designations from the US Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD). 8 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted US biotech Vera Therapeutics’ Trutakna (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression. 8 July 2026
Pharmaceutical
Privately held, clinical-stage US pharmaceutical company Saol Therapeutics today announced the resubmission of its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease. 7 July 2026
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. 7 July 2026
Biotechnology
The European Commission has approved Danish biotech Genmab and US pharma major AbbVie’s Tepkinly (epcoritamab) in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma, widening the bispecific antibody’s European label into an earlier treatment setting 7 July 2026
Biotechnology
Taiwan-based PharmaEssentia yesterday announced that its wholly owned subsidiary, FORUS Therapeutics, has received a Notice of Compliance (NOC) from Health Canada, authorizing the use of Besremi (ropeginterferon alfa-2b) for the treatment of adults diagnosed with polycythemia vera (PV). 7 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has issued a warning letter to Genzyme Ireland, a Sanofi subsidiary, citing significant manufacturing violations at its Waterford biologics plant following an inspection in January. 6 July 2026
Pharmaceutical
Regulators in the USA, Japan, the UK, Switzerland, Australia and several other major international markets have issued a mix of safety statements, review updates, guidance changes, compliance notices and regulatory procedure updates over the past week, reflecting continued activity across pharmacovigilance, labelling, medicine supply, biosimilars, e-labelling and unauthorized products. 6 July 2026
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
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
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. 13 July 2026
Pharmaceutical
Last week’s regulatory news saw the US Food and Drug Administration (FDA) accept Swiss biotech Pharmvaris’ new drug application (NDA) for deucrictibant for the treatment hereditary angioedema (HAE) attacks. The FDA also approved Sanofi’s Sarclisa Escensa. On the M&A front, US drugmaker Vertex announced a $10 billion takeover bid for Crinetics and its rare disease drug Palsonify. Also of note, the UK’s AstraZeneca released disappointing Phase III trial results for its Wainua in cardiopathy. 12 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved pharma giant Pfizer and Japanese drugmaker Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) plus Merck & Co’s Keytruda (pembrolizumab) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. 10 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. 10 July 2026
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