Life science news 1 June 2026: FDA approvals, a landmark obesity pill advance and a $10.5 billion Pfizer partnership define a milestone week for pharma and biotech.
The week of 24 to 30 May 2026 delivered a string of significant regulatory milestones, high-value industry deals and a major UK regulatory development. AbbVie and MannKind both secured FDA approvals for first-in-class medicines, Novo Nordisk won EU regulatory backing for its Wegovy pill, and Pfizer announced a $10.5 billion oncology collaboration with Innovent Biologics. In the UK, the Medicines and Healthcare products Regulatory Agency launched one of the most significant rare disease regulatory reforms in decades.
AbbVie received FDA approval on 27 May for Decnupaz (pivekimab sunirine-pvzy), becoming the first antibody-drug conjugate (ADC) approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and aggressive blood cancer affecting 500 to 1,000 patients in the US each year. The approval, supported by data from the Phase 1/2 CADENZA trial, marks AbbVie’s first ADC authorisation in the blood cancer space. In treatment-naive patients, Decnupaz achieved a complete or clinical complete remission rate of 69.7% at a median follow-up of 21.5 months. The drug is administered intravenously in an outpatient setting and carries a boxed warning for hepatotoxicity.
Pfizer and China-based Innovent Biologics announced on 28 May a strategic global licensing and collaboration agreement valued at up to $10.5 billion, covering the research and development of 12 early-stage cancer medicines. The portfolio spans ADCs with novel payloads and multi-specific antibodies across eight Innovent-originated programmes and four Pfizer-proposed discovery programmes. Innovent will receive a $650 million upfront payment from Pfizer, with up to $9.85 billion in additional development, regulatory and commercial milestone payments. The deal is intended to combine Pfizer’s global clinical development and regulatory capabilities with Innovent’s oncology discovery expertise, with co-development and co-commercialisation rights for select programmes.
CVS Caremark announced on 28 May that it will restore coverage of Eli Lilly’s Zepbound injection as a preferred option from 1 October 2026, and will add Lilly’s oral obesity medicine Foundayo (orforglipron) to its formularies from 1 June 2026. The decision means Lilly’s full obesity portfolio is now covered by all three of the largest US pharmacy benefit managers, which together control approximately 80% of national prescription claims. Eligible patients with commercial coverage will be able to access both medicines for as little as $25 per month. Lilly’s share price rose nearly 6% on the announcement and briefly reached an all-time high market capitalisation of approximately $1.02 trillion.
Novo Nordisk announced on 22 May that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending marketing authorisation of the Wegovy pill (once-daily oral semaglutide 25mg) for weight management in the EU, making it the first oral GLP-1 receptor agonist to receive a CHMP recommendation for obesity. The recommendation is based on data from the OASIS trial programme, in which oral semaglutide demonstrated 16.6% mean weight loss among patients who adhered to treatment in the OASIS 4 trial, and includes cardiovascular outcome data from the SELECT trial in the label. Novo Nordisk plans to launch the Wegovy pill in select markets outside the US in the second half of 2026, with the US launch having already attracted more than one million users within its first four months.
Merck announced on 29 May that the FDA had granted Breakthrough Therapy Designation to calderasib (MK-1084), its investigational oral KRAS G12C inhibitor, in combination with Keytruda (pembrolizumab), for the first-line treatment of patients with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer expressing PD-L1. The designation, the first for calderasib, was supported by data from the Phase 1 KANDLELIT-001 trial in which the combination achieved an objective response rate of 77% in patients with this mutation. The KRAS G12C mutation occurs in approximately 14% of patients with non-small cell lung cancer adenocarcinoma, making it the most common KRAS mutation in this cancer type. Merck is running five Phase 3 trials of calderasib across multiple tumour types. The calderasib Breakthrough Therapy Designation was one of the more significant pipeline milestones in life science news 1 June 2026, adding to Merck’s post-Keytruda growth strategy as the blockbuster faces its 2028 patent expiry.
MannKind Corporation received FDA approval on 29 May for an expanded label for Afrezza (insulin human) Inhalation Powder, covering children and adolescents aged 6 and older with type 1 or type 2 diabetes. The approval makes Afrezza the first needle-free mealtime insulin option for paediatric patients in more than 100 years of insulin therapy, delivered via MannKind’s Technosphere inhaled drug delivery platform. The approval was supported by the Phase 3 INHALE-1 trial, which enrolled 230 patients aged 4 to 17 and compared inhaled insulin to multiple daily injections. The trial reported higher treatment satisfaction among paediatric patients and parents in the Afrezza arm.
Sanofi announced on 28 May that the FDA had granted priority review to its new drug application for venglustat, an investigational oral glucosylceramide synthase inhibitor, for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder in which abnormal molecules accumulate in the central nervous system, causing progressive neurological decline. If approved, venglustat would become the first treatment in the US to address the neurological manifestations of GD3, and the FDA has set a target action date of 25 November 2026. Venglustat previously received Breakthrough Therapy and fast-track designations for this indication and is also under regulatory review in the EU.
In further life science news 1 June 2026, the week also brought a significant regulatory development from the UK, where the Medicines and Healthcare products Regulatory Agency launched a landmark consultation that could reshape how rare disease therapies are developed and approved in Britain.
The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on 21 May on a proposed Rare Disease Therapies Regulatory Framework, described as one of the most significant regulatory reforms for rare disease treatment development in decades. The framework proposes a new Investigational Marketing Authorisation pathway, which would combine clinical trial approval with a progressive route to full licensing, specifically designed for conditions affecting no more than one in 50,000 people in the UK. Rare diseases affect approximately 3.5 million people in the UK, yet fewer than 5% of those conditions currently have an approved treatment. The consultation is open until 20 July 2026, with the MHRA calling for input from pharmaceutical companies, biotechnology developers, patient organisations, academics, and clinicians.
That’s your life science news digest for 1 June 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news.
Missed last week’s roundup? Read the Weekly News Roundup for 25 May 2026 here.
This weekly digest is produced by the Life Science Daily News editorial team. All stories are selected and written independently.
