Regulation

MediciNova has finished the double-blind portion of its 234-patient Phase 2b/3 ALS trial and expects topline results by end of 2026.

China's CDE has granted Breakthrough Therapy Designation to NXP200, a brain-penetrant BRAF inhibitor, for recurrent BRAF V600-mutant high-grade glioma.

The New York BCI company raised an oversubscribed round co-led by Pershing Square, bringing total funding to $430m since its 2021 founding.

The Cambridge biotech's in vivo Prime Editor targets the root genetic cause of alpha-1 antitrypsin deficiency, with first-in-human data expected in

Seven of eight enrolled participants met the primary endpoint in the upLIFT Phase 3 study; topline results are expected before end of 2026.

Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.

The Oxford immuno-oncology company has agreed a structured loan facility with BlackRock to help finance its registrational melanoma trial, due to start by end

Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.

Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal

The Barcelona-based medtech secured $56m led by Omega Funds to complete the ATHENA pivotal IDE study of its ANA Funnel Catheter in ischaemic stroke.

An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.

Lirafugratinib becomes a second-line option for FGFR2-rearranged cholangiocarcinoma after posting a 46% confirmed response rate in the ReFocus trial.

PhAST Corp.'s Gram-negative panel delivers antimicrobial susceptibility results in under 2.5 hours directly from positive blood cultures, cutting a typical 24-48

Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.

SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in

The French plant-based ingredients group lifted H1 turnover to €2.6bn, with pharmaceutical excipients and its Shift & Lead transformation plan driving margin improvement.

Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.

ATCC will lead lifecycle management of vaccines, biologics and drugs for the US military's RAPID programme under a 10-year, $99 million contract.

Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for

Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six