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- 86articles · 30d
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News
Reviews underway of first drug for rare disease MOGAD
3+ day, 1+ hour ago (417+ words) Patients with a rare autoimmune disease known as MOGAD could be just a few months away from having the first approved treatment. The FDA has just started a priority review of Roche's anti-IL-6 inhibitor Enspryng (satralizumab) for MOGAD – myelin oligodendrocyte…...
Bayer moves Hyrnuo into frontline lung cancer treatment
3+ day, 2+ hour ago (562+ words) Bayer has won FDA approval for oral HER2 inhibitor Hyrnuo as a first-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), just a year after it was cleared as a second-line option. Hyrnuo (sevabertinib) has been cleared for earlier use…...
FDA starts review of AZ's COPD blockbuster hope
4+ day, 1+ hour ago (616+ words) The FDA has started a priority review of AstraZeneca's IL-33-targeting antibody tozorakimab for chronic obstructive pulmonary disease (COPD), setting up a decision on the would-be blockbuster in the first quarter of 2027. It's an indicator of AZ's excitement about tozorakimab that…...
Brainomix AI lends weight to Endeavor Bio's IPF trial data
4+ day, 3+ hour ago (565+ words) An AI-powered imaging tool developed by Brainomix has been used to enrich data from a phase 2a trial of Endeavor BioMedicines' hedgehog pathway inhibitor taladegib, in development for idiopathic pulmonary fibrosis (IPF). The post hoc analysis of the study showed that…...
Who's Speaking at the DIA-MHRA Global Summit 2026?
4+ day, 4+ hour ago (267+ words) Dame Kate Bingham completes the confirmed line-up. Best known for chairing the UK's Vaccine Taskforce during the COVID-19 pandemic, she brings a venture capital and drug development perspective on what it takes to move quickly from science to approved product…...
US puts $125m into personalised RNA therapy production
1+ week, 4+ day ago (539+ words) The US Advanced Research Projects Agency for Health (ARPA-H) has awarded $125 million in funding, split across five groups, to build a network for producing 'made-to-order' RNA-based genetic medicines. The Genetic Medicines and Individualised Manufacturing for Everyone (GIVE) programme will replace…...
Decarbonising respiratory care requires a new kind of generics innovation
1+ week, 4+ day ago (422+ words) Generics manufacturers have long played a critical role in supporting the sustainability of the NHS, delivering affordable medicines at scale, expanding patient access, and helping healthcare systems manage increasing demand under growing financial pressure. But as the NHS accelerates towards…...
Decentralisation by design: Bringing the trial closer without adding complexity
2+ week, 5+ day ago (227+ words) As clinical trials become more complex, sponsors face growing pressure to reach more representative patient populations while reducing participation burden and keeping studies moving without adding strain to sites. In the third episode of our PSCS leadership discussion series, developed…...
Roche’s Genentech strikes $2.3bn deal for Hanmi obesity drug HM17321
2+ week, 5+ day ago (354+ words) Roche’s Genentech has agreed a deal worth up to $2.3 billion to develop and sell Hanmi Pharmaceutical’s experimental obesity drug HM17321, as the US-based drugmaker looks to explore treatments that can preserve muscle alongside weight loss. Genentech will pay Hanmi $190 million upfront…...
Ultragenyx wins FDA approval for first treatment targeting root cause of GSDIa
3+ week, 2+ day ago (384+ words) US biopharma Ultragenyx has secured its first gene therapy approval, with the FDA clearing GENGLYCOS as the first treatment designed to address the underlying cause of the ultra-rare metabolic disorder, glycogen storage disease type Ia (GSDIa). GSDIa is caused by…...