Life science news 18 May 2026: FDA leadership turmoil, a landmark Alzheimer’s breakthrough and a $15 billion China licensing deal define a historic week for the global industry.
The week of 10 to 17 May 2026 delivered a concentration of high-impact events across regulatory affairs, dealmaking and clinical science that will shape the sector for years ahead. The resignation of FDA Commissioner Marty Makary sent shockwaves through the regulatory community, Biogen reported the first Phase 2 evidence of cognitive benefit from a tau-targeting Alzheimer’s therapy, Bristol Myers Squibb sealed its largest ever licensing agreement with China’s Hengrui Pharma, and AstraZeneca and Daiichi Sankyo secured two major FDA approvals for Enhertu in early-stage breast cancer. Alongside these headline events, Novo Nordisk delivered a substantial data package at the European Congress on Obesity in Istanbul, and the UK’s medicines regulator published a strong set of annual results.
FDA Commissioner Dr Marty Makary resigned on 12 May after 14 months in post, following mounting friction with the Trump administration over a range of regulatory decisions including the authorisation of fruit-flavoured e-cigarettes, which Makary opposed. President Trump announced on Truth Social that Kyle Diamantas, the FDA’s Deputy Commissioner for Food and a lawyer with no medical degree, would serve as acting commissioner. Makary’s tenure was marked by mass staff departures, unexpected drug rejections, and persistent tension between the Make America Healthy Again movement and pharmaceutical industry groups demanding regulatory predictability. The agency now has temporary directors in three senior positions simultaneously, raising significant questions about continuity across drug approval, clinical trial, and post-market safety programmes.
Biogen announced on 14 May that its Phase 2 CELIA study of diranersen (BIIB080), an antisense oligonucleotide therapy targeting tau protein, produced the first evidence from a randomised trial of a tau-directed agent demonstrating both robust biomarker reduction and cognitive benefit in early Alzheimer’s disease. The study, which enrolled more than 400 patients with mild cognitive impairment or mild Alzheimer’s dementia, tested three escalating doses against placebo over 76 weeks. Although the trial failed its primary endpoint of a dose-response change in disease severity, the lowest dose produced the most compelling results and Biogen confirmed it will advance diranersen to registrational Phase 3 development. Full data will be presented at the Alzheimer’s Association International Conference in July. Analysts at RBC Capital Markets described any mechanism showing cognitive benefits in Alzheimer’s as a potential long-term win, with the data also boosting broader interest in tau-targeting programmes at companies including Denali Therapeutics.
Bristol Myers Squibb and China’s Hengrui Pharma announced on 12 May a global strategic collaboration and licensing agreement covering a portfolio of 13 early-stage programmes across oncology, haematology and immunology. BMS will pay Hengrui up to $950 million in staged upfront-related payments, including $600 million immediately, $175 million on the first anniversary of closing, and a further contingent $175 million in 2028. The potential total value of the agreement reaches approximately $15.2 billion, including milestone payments and tiered royalties on net sales outside mainland China, Hong Kong and Macau. The deal, ranked as the second-largest China-to-West licensing agreement since the start of 2025, covers four oncology and haematology assets originating from Hengrui, four immunology assets originating from BMS, and five jointly discovered programmes. Closing is expected in the third quarter of 2026, subject to Hart-Scott-Rodino antitrust clearance.
AstraZeneca and Daiichi Sankyo received FDA approval on 15 May for Enhertu (trastuzumab deruxtecan) in two new settings for HER2-positive early-stage breast cancer. The first approval covers neoadjuvant treatment for adult patients with HER2-positive Stage II or Stage III breast cancer, based on the DESTINY-Breast11 Phase III trial. The second covers adjuvant treatment for patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant HER2-targeted therapy, supported by the DESTINY-Breast05 trial. Both applications were reviewed under Project Orbis, the FDA’s framework for concurrent international regulatory review. Enhertu is already approved in more than 95 countries for HER2-positive metastatic breast cancer, and the new approvals meaningfully expand its reach to patients at high risk of disease recurrence at an earlier stage of treatment.
Novo Nordisk presented 52 scientific abstracts at the European Congress on Obesity in Istanbul between 12 and 15 May, covering Wegovy at standard and higher doses, the oral Wegovy pill (oral semaglutide 25 mg), and the investigational combination therapy CagriSema. New data from the OASIS 4 trial showed that early responders to the Wegovy pill achieved an average of 21.6% weight loss, with improvements in physical function and mobility also reported. CagriSema data from the REDEFINE programme addressed body composition, muscle strength, and physical function, metrics analysts believe will be pivotal to differentiating the candidate from existing GLP-1 therapies if its weight-loss efficacy advantage proves modest. Novo Nordisk reported approximately 135,000 weekly US prescriptions for oral Wegovy in the week ending 24 April, maintaining a clear lead over Eli Lilly’s recently approved oral GLP-1 therapy, Foundayo.
In further life science news 18 May 2026, Valneva announced on 13 May that it will cut between 10% and 15% of its global workforce as part of a restructuring plan designed to streamline operations and reduce costs. The French vaccine specialist, whose portfolio includes the Japanese encephalitis vaccine Ixiaro and the cholera vaccine Dukoral, reported a first-quarter 2026 revenue decline to €30.9 million from €49.2 million a year earlier, which it attributed in part to an emerging adverse trend in travel vaccine uptake across key markets driven by geopolitical factors. The company also lowered its full-year product sales guidance and said the combined restructuring measures are expected to reduce 2026 operating expenses by 25% to 35% compared with 2025 levels.
The Scottish Medicines Consortium published its May 2026 decisions on 11 May, recommending enfortumab vedotin (Padcev) in combination with pembrolizumab (Keytruda) for the first-line treatment of adults in Scotland with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. The combination, which pairs Astellas and Pfizer’s antibody-drug conjugate with Merck’s checkpoint inhibitor, has demonstrated significantly improved overall survival compared with standard platinum-based chemotherapy. Bladder cancer is the ninth most common cause of cancer death in the UK, with around 200 people in Scotland diagnosed each year with unresectable or metastatic disease. The SMC also recommended amivantamab with lazertinib for first-line advanced non-small cell lung cancer with specific mutations, and durvalumab as the first treatment option for adults with limited-stage small cell lung cancer whose disease has not progressed after chemoradiotherapy. The SMC’s May decisions were a positive access story in life science news 18 May 2026, expanding treatment options for Scottish patients across bladder cancer, lung cancer and other serious conditions.
That’s your life science news 18 May 2026 digest, 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 11 May 2026 here.
This weekly digest is produced by the Life Science Daily News editorial team. All stories are selected and written independently.
