Life science news 28 September 2026: four US drug approvals, three UK developments and two global R&D deals.
The FDA approved Atebrioz, the third treatment for fibrodysplasia ossificans progressiva, and AbbVie’s Parkinson’s drug Juvmo. The MHRA approved lurbinectedin for extensive-stage small cell lung cancer. InnoCare and Eli Lilly signed a drug discovery deal worth up to 3.35 billion dollars.
The FDA approved Atebrioz (zilurgisertib) on 25 September 2026. Mirum Pharmaceuticals and Incyte announced the decision jointly. Atebrioz is a once-daily oral ALK2 inhibitor for fibrodysplasia ossificans progressiva (FOP), a rare bone disorder. It is approved to reduce the volume of total new heterotopic ossification, or abnormal bone growth. The approval covers adults and children aged 12 and over. The FDA describes it as the third approved treatment for the disease. Incyte discovered zilurgisertib. Mirum holds the licence for worldwide development and commercialisation. No financial terms were disclosed for that arrangement. The label also carries a caution about foetal harm shown in animal studies.
In the Phase 2 PROGRESS trial, 63 patients took zilurgisertib or a placebo for 24 weeks. Mean new bone growth volume fell by 3.2 cubic centimetres on zilurgisertib. It rose by 24.6 cubic centimetres on placebo. Mirum and Incyte said the effect held through 48 weeks of open-label follow-up. Mirum chief executive Chris Peetz called it “an important milestone for people living with FOP.” Robert Pignolo of Mayo Clinic, the PROGRESS lead investigator, said another option is “meaningful in a progressive disease like FOP.” Patients of reproductive potential are advised to use effective contraception.
The MHRA approved lurbinectedin, sold as Zepzelca, on 23 September 2026. PharmaMar makes the drug. It is used alongside atezolizumab as maintenance therapy. The approval covers adults with extensive-stage small cell lung cancer. Patients must have had no disease progression after first-line treatment. That induction regimen combines atezolizumab, carboplatin and etoposide. The decision gives UK clinicians a new maintenance option for a hard-to-treat cancer. Routine NHS funding in England is decided separately by NICE. Small cell lung cancer often returns quickly after initial chemotherapy. Extensive-stage disease accounts for most small cell lung cancer diagnoses at presentation.
The trial behind the approval enrolled 483 adults. Patients lived a median of 13.2 months on the combination. Those on atezolizumab alone lived 10.6 months. Progression-free survival was 5.4 months against 2.1 months for atezolizumab alone. Common side effects include nausea, fatigue, anaemia and low blood cell counts. The MHRA’s Julian Beach said the approval “provides a new treatment option for adults with extensive-stage small cell lung cancer.” He is the regulator’s executive director of healthcare quality and access. Suspected side effects should be reported through the MHRA’s Yellow Card scheme.
The FDA approved Lyrfigtu (lirafugratinib) on 23 September 2026. It is a standard approval, granted under priority review. Elevar Therapeutics expects the drug to be available in the United States by the fourth quarter. Elevar is majority owned by South Korea’s HLB. Lyrfigtu is an oral, irreversible FGFR2 inhibitor. It treats previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma. Eligible tumours carry an FGFR2 gene fusion or other rearrangement. Elevar licensed the drug from Relay Therapeutics for worldwide commercialisation. Elevar describes it as a second-line option for bile duct cancer. Bile duct cancer is often diagnosed late, and treatment options remain limited.
The approval rests on the single-arm REFOCUS trial. It enrolled 116 patients who had not previously taken an FGFR inhibitor. All had received prior chemotherapy or chemoimmunotherapy. The confirmed objective response rate was 46 per cent. Median duration of response reached 11.8 months. Elevar reported median progression-free survival of 11.3 months. Stanford’s Lipika Goyal said the drug’s “unique, irreversible, covalent-binding mechanism enables potent and sustained inhibition of FGFR2.” UCSF’s Robin Kate Kelley said Lyrfigtu “achieved remarkably deep and durable treatment responses.” The label warns of ocular toxicity, hyperphosphataemia and embryo-foetal toxicity. Elevar reported retinal pigment epithelial detachment in 31 per cent of patients.
The UK and Singapore launched talks on a new pharmaceutical manufacturing agreement on 22 September 2026. The Department for Business, Innovation, Science and Trade announced the talks the following day. Negotiators are working towards a mutual recognition agreement. It would let regulators rely on each other’s manufacturing inspections. That would cut duplicate testing for medicines moving between the two countries. UK-Singapore goods trade reached 12 billion pounds in 2025. That marked a 24 per cent rise on the previous year. Medicines trade between the countries topped 300 million pounds in 2025.
Trade minister Lord Sarwar called the relationship a “thriving trade partnership.” He said the new agreement would help it go further. He said cutting red tape would “reduce costs for businesses.” It would also support jobs and drive growth in the life sciences sector, he said. The department said the South East of England, the East of England and Wales would benefit in particular. No date has been set for concluding the talks. The MHRA and Singapore’s Health Sciences Authority both belong to the Access Consortium of regulators. The announcement said the agreement would build on “strong existing bilateral cooperation between our regulators.”
In further life science news 28 September 2026, the week also brought fresh developments. Two more FDA approvals, a UK enforcement case and two research deals followed.
The FDA approved Onswik (insulin efsitora alfa-gobe) on 23 September 2026. Eli Lilly announced the decision the following day. Lilly developed the once-weekly basal insulin. It treats adults with type 2 diabetes alongside diet and exercise. The FDA said Onswik is the second once-weekly insulin approved for adults with type 2 diabetes. The approval rested on the Phase 3 QWINT programme. More than 3,400 adults took part across four studies. Two trials compared Onswik with insulin glargine. Two others compared it with insulin degludec. The FDA said Onswik lowered HbA1c to a similar extent as both daily insulins.
Lilly says patients on Onswik need only 52 injections a year. That compares with 365 injections on a daily basal insulin. Kenneth Custer is president of Lilly Cardiometabolic Health. He said “the burden of daily injections can have a real impact on patients’ day-to-day experience.” Onswik is not recommended for people with type 1 diabetes. The FDA cited a higher risk of severe hypoglycaemia. Other precautions include medication errors, accidental overdose, hypersensitivity reactions and low potassium. The FDA also flags fluid retention and heart failure when used with certain other medicines.
The FDA approved Juvmo (tavapadon) on 25 September 2026. The FDA’s novel drug approvals list gives its use as treating Parkinson’s disease in adults. AbbVie gained the drug through its acquisition of Cerevel Therapeutics, agreed in 2023 for 8.7 billion dollars. Juvmo is a once-daily oral tablet. It mimics dopamine, a brain chemical that is depleted in Parkinson’s disease. Reuters reported the approval, citing the FDA website. LSDN could not find an AbbVie announcement at the time of writing. More than 11 million people worldwide live with Parkinson’s disease, according to Reuters.
AbbVie based its 2025 application on the Phase 3 TEMPO programme. TEMPO-1 and TEMPO-2 tested tavapadon alone in early Parkinson’s disease. TEMPO-3 tested it alongside levodopa in advanced disease with motor fluctuations. AbbVie describes tavapadon as a selective D1/D5 receptor partial agonist. Reuters reported common side effects of nausea, dizziness and headache. AbbVie did not respond to Reuters’ questions on launch timing or pricing. LSDN had not been able to review the full US label at the time of writing.
A Bolton businessman was sentenced on 23 September 2026 over falsely certified medical devices. Kenneth George Harrison, 70, supplied enteral feeding pumps, gastrostomy button devices and blunt fill needles. The devices bore invalid CE marking and were used in hospitals across the UK. The MHRA first identified concerns in 2013 and pursued the case for more than a decade. At Manchester Crown Court, Harrison received a three-year prison sentence, suspended for three years. He must also complete 175 hours of community service and 10 days of rehabilitation activity. Harrison was disqualified from acting as a company director for eight years. Medicina Limited will be sentenced separately.
James Pound, the MHRA’s executive director of innovation and compliance, welcomed the sentencing. He said it had “been a long and complex investigation.” He said the outcome “demonstrates our commitment to taking robust enforcement action.” The enteral feeding pumps were used in neonatal intensive care and special care baby units. They fed very sick newborn babies directly into their stomachs. The affected pumps were ultimately removed from the UK and EU markets.
InnoCare Pharma and Eli Lilly announced a drug discovery deal on 24 September 2026. InnoCare is a Chinese biopharmaceutical company listed in Hong Kong and Shanghai. InnoCare will discover and advance compounds against up to five targets. The companies described the arrangement as a research collaboration and licence agreement. The deal could bring InnoCare up to 3.35 billion dollars in total. That includes up to 100 million dollars in upfront and near-term payments. It also includes up to roughly 3.25 billion dollars in development and commercial milestones.
InnoCare will also receive single-digit tiered royalties on net sales of any approved product. InnoCare’s Jasmine Cui said the deal lets it “leverage our R&D platform to collaborate with a global pharmaceutical leader.” Cui is the company’s co-founder, chairwoman and chief executive. The announcement did not include a quote from Lilly. InnoCare has three approved drugs: orelabrutinib, tafasitamab and zurletrectinib. The company has more than ten other candidates in clinical development.
AbbVie and Iambic Therapeutics announced an artificial intelligence drug discovery deal on 21 September 2026. The multi-year collaboration spans immunology, neuroscience and oncology. Iambic will apply its Enchant and NeuralPLexer platforms to small molecule discovery. Iambic will receive an upfront payment, milestone payments and royalties on any resulting products. The companies did not disclose specific dollar figures for the arrangement. Iambic also filed for a Nasdaq listing on the same day, under the proposed ticker IAM.
Nicholas Donoghoe is AbbVie’s chief business and strategy officer. He said AI “will be a powerful catalyst for scientific innovation across AbbVie.” Jonathon Sedgwick, AbbVie’s global head of discovery research, said the goal was “to design better molecules more efficiently.” Iambic chief executive Tom Miller said his company was “eager to bring Iambic’s molecular superintelligence platform to bear.” Iambic’s lead programme, IAM1363, is a brain-penetrant HER2 inhibitor in Phase 1/1b testing for solid tumours. The deal adds AbbVie to a growing list of drug makers using AI for early discovery.
That’s your life science news digest for 28 September 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news.
Catch up on the 21 September news roundup.
