Clinical trials, drug development and research news
Drug ApprovalsThe FDA approved Bayer's asundexian for use with antiplatelet drugs after a recent stroke or high-risk TIA, after it cut ischaemic strokes by 26%. It is not approved for atrial fibrillation.
9 November 2026
Rare DiseasesIn two phase 3 trials, seladelpar and elafibranor brought a key liver blood test back to normal for most people with milder primary biliary cholangitis, against few on placebo.
8 November 2026
In the phase 3 X-TOLE2 trial, once-daily azetukalner cut monthly focal seizures by a median 53% at the higher dose, against 10% on placebo, in drug-resistant epilepsy. Adding a once-daily capsule called azetukalner cut focal seizures by a median of 53% at its higher dose in the phase 3 X-TOLE2 trial, against about 10% with a placebo.
· 9 November 2026
The Briefing
One email. The week's readouts, approvals and research, explained without hype.
OncologyIn the KEYNOTE-C93 trial, pembrolizumab without chemotherapy kept dMMR endometrial cancer in check for a median 38.2 months, against 8.4 months with chemotherapy, with fewer severe side effects.
26 October 2026
OncologyAdding savolitinib to osimertinib extended median survival from 12.9 to 17.8 months against chemotherapy in EGFR lung cancer driven by high MET levels, the SAFFRON trial found.
25 October 2026
OncologyRoche's divarasib kept KRAS G12C lung cancer in check for 9.8 months against 5.7 on sotorasib or adagrasib, and people taking it lived about six months longer.
25 October 2026
OncologyAdding tarlatamab to durvalumab maintenance raised median survival from 12.7 to 21.1 months in extensive-stage small cell lung cancer, with mostly mild immune reactions.
24 October 2026
OncologyIn the VOLGA trial, durvalumab plus enfortumab vedotin around bladder removal lifted two-year survival from 69% to 78% for people who couldn't or wouldn't have cisplatin.
24 October 2026
Rare DiseasesIn two phase 3 trials, seladelpar and elafibranor brought a key liver blood test back to normal for most people with milder primary biliary cholangitis, against few on placebo.
8 November 2026
Rare DiseasesDeramiocel slowed heart scarring and protected pumping strength in boys with Duchenne cardiomyopathy, HOPE-3 data show, but the main cardiac test missed and the FDA rules by 22 November.
7 November 2026
Rare DiseasesIn the Lancet-published RISE UP trial, mitapivat raised haemoglobin in 41% of people with sickle cell disease against 3% on placebo, but pain crises didn't fall significantly.
22 October 2026
Rare DiseasesIn the ORIGIN 3 trial, people with IgA nephropathy on weekly atacicept lost almost no kidney function over two years, against about 5.6 eGFR units a year on placebo.
22 October 2026
Rare DiseasesPhase 3 APOLLO results show bitopertin added about 12 pain-free hours in light each month and cut painful reactions by 71% in erythropoietic protoporphyria, a rare inherited condition.
19 October 2026
CardiologyIn the 8,322-patient Lp(a) HORIZON trial, monthly pelacarsen injections slashed lipoprotein(a) levels, but heart attacks, strokes and heart deaths stayed level with placebo for almost five years.
7 November 2026
CardiologyIn two phase 3 trials of 757 adults, plozasiran lowered triglycerides by about 80% and cut acute pancreatitis rates, though the result rests on 18 attacks over a single year.
4 November 2026
CardiologyIn PROGRESS, early TAVR cut death or heart failure events by a third versus clinical surveillance at two years in 744 people with moderate aortic stenosis and at-risk features.
2 November 2026
CardiologyIn PADN-HF-PH, adding pulmonary artery denervation to standard medicines halved clinical worsening in heart failure patients with raised lung pressure over about a year.
30 August 2026
CardiologyIn the TRIC-I-HF trial, repairing the tricuspid valve through a vein raised the share alive and out of hospital at three years from 21% to 52%.
30 August 2026
NeurologyIn the phase 3 X-TOLE2 trial, once-daily azetukalner cut monthly focal seizures by a median 53% at the higher dose, against 10% on placebo, in drug-resistant epilepsy.
9 November 2026
NeurologyIn OPTIMAL-STROKE, a systolic target below 120 instead of 140 meant fewer heart attacks, strokes and related admissions over four years, with more kidney test changes.
7 November 2026
NeurologyIn the REMODEL trials of 2,007 people, remibrutinib cut relapses by about a third and new brain lesions by two thirds against teriflunomide, without liver problems.
23 October 2026
NeurologyThe long-delayed Cognite trial of 619 people found inhaled cromolyn plus low-dose ibuprofen did no better than either drug alone, with a non-significant signal in APOE4 non-carriers.
23 October 2026
NeurologyIn the LATE-MT trial, thrombectomy 24 to 72 hours after a major stroke helped more people regain independence, but raised brain bleeding and deaths.
23 October 2026
Drug ApprovalsThe FDA approved Bayer's asundexian for use with antiplatelet drugs after a recent stroke or high-risk TIA, after it cut ischaemic strokes by 26%. It is not approved for atrial fibrillation.
9 November 2026
Drug ApprovalsAn injection of amivantamab shrank tumours in 42% of people whose head and neck cancer returned after immunotherapy and chemotherapy, earning FDA accelerated approval on 5 November.
5 November 2026
Drug ApprovalsVoceryq won accelerated approval after a trial of 32 adults in which about a quarter needed no surgery for their papillomas in the following year.
30 October 2026
Drug ApprovalsThe MHRA has extended Casgevy to children from age five with severe sickle cell disease or thalassaemia, and NICE has widened NHS managed access to match.
30 October 2026
Drug ApprovalsThe FDA has cleared talazoparib with enzalutamide for gene-mutated hormone-sensitive prostate cancer after TALAPRO-3 cut the risk of scan progression or death by 52%.
26 October 2026
Industry & RegulationSix months into the UK's new clinical trial regulations, the MHRA reports seven-day average approvals for low-risk changes and lists the mistakes that still delay applications.
28 October 2026
Industry & RegulationThe UK regulator's five-year plan sets guaranteed assessment times backed by fee rebates, an AI protocol checker and a goal of third place globally for phase 1 trials.
14 October 2026
Industry & RegulationThe EMA says the proposed Biotech Act affects about 70% of the EU clinical trials system, with first changes possible in 2028 as the FAST-EU pilot tests 70-day approvals.
1 October 2026
Industry & RegulationThe Council has adopted the biggest rewrite of EU medicines law in two decades, changing protection periods, orphan exclusivity, antibiotic incentives and EMA review times.
28 September 2026
Industry & RegulationDrug sponsors can now pair with qualified research institutions for rolling FDA review of investigational new drug applications, as the agency tries to shorten first-in-human timelines.
15 September 2026