Disease

Pharmaceuticals
Genomics

Belite Bio to present DRAGON Phase 3 tinlarebant data at Euretina

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Pharmaceuticals
Genomics
Regulatory Science

Oryzon secures EMA approval to start HOPE-2 vafidemstat trial in PMS

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Pharmaceuticals
Biologics

SCYNEXIS wins $214m BARDA contract to develop SCY-247 antifungal

The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
The NASDAQ-listed biotech secured up to $214m in non-dilutive federal funding to advance its second-generation fungerp candidate through NDA submission.
Biologics
Pharmaceuticals

Teva wins FDA approval for DEGEVMA denosumab biosimilar to Xgeva

Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Teva's DEGEVMA completes a full denosumab biosimilar portfolio covering both Xgeva and Prolia indications in the US market.
Pharmaceuticals
Biotech

Addex Therapeutics posts H1 2026 loss as cash falls to CHF 0.8m

Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Addex reported a net loss of CHF 3.5m for the first half of 2026, with cash at CHF 0.8m after an ATM raise
Biologics
Pharmaceuticals

Annexon to present ARCHER II baseline data at Retina Society meeting

Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Annexon will give two oral presentations on vonaprument at the Retina Society annual meeting, with Phase 3 month-15 results expected in Q4 2026.
Pharmaceuticals
Biologics

Boehringer Ingelheim funds WHO Foundation obesity drive with $5m

The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
The German pharma group will contribute $5 million over three years to strengthen obesity and metabolic health systems in resource-limited settings.
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject strengthens balance sheet as BARDA deal extended to $48m

The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
Cell & Gene Therapy
Biologics
Regulatory Science

Ocugen's OCU400 gains provisional approval in The Bahamas for RP

Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Ocugen's modifier gene therapy OCU400 has received provisional LARTA approval in The Bahamas, enabling expanded access for retinitis pigmentosa patients within 90 days.
Biologics
Pharmaceuticals

Absci plans Phase 2 STORYLINE trial of ABS-201 for endometriosis

Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Absci will launch a global, placebo-controlled Phase 2 study of its AI-designed anti-PRLR antibody ABS-201 in endometriosis patients from mid-2027.
Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Digital Health

Chrysalis Health and Curaechoice partner on no-cost mental health access

The tie-up gives self-funded employer health plan members access to Chrysalis Health's 80-plus outpatient sites and virtual services at no out
The tie-up gives self-funded employer health plan members access to Chrysalis Health's 80-plus outpatient sites and virtual services at no out
Cell & Gene Therapy
Biologics

CIRM awards $9m to Enloe Health for Northern California CGT centre

The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
Pharmaceuticals
Diagnostics

Milestone Pharma enrols first Canadian patient in AFib-RVR trial

Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Medical Devices
Digital Health

neurocare and Wave Neuroscience partner on EEG-guided PTSD therapy

The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.
The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.
Pharmaceuticals
Regulatory Science

Newron's ENIGMA-TRS 2 US enrolment hold stays as ex-US sites expand

The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
Pharmaceuticals
Biologics

PridCor Therapeutics advances Phase 2 SHIELD Long COVID study

The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
Pharmaceuticals

Vistagen sees fasedienol signal in severe social anxiety

Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Diagnostics
Biologics
Cell & Gene Therapy

Adaptive Biotechnologies cites clonoSEQ in new myeloma cure definition

A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
Pharmaceuticals
Biologics

Addex regains global GABAB PAM rights after Indivior R&D pullback

Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Subscribe to Disease