North America

The United States and Canada.
Biologics
Pharmaceuticals

Tectonic Therapeutic reports clean Phase 1a data for HHT drug

TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
Cell & Gene Therapy
Genomics

uniQure AMT-130 shows 80% disease slowing at 36 months in HD trial

Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.
Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.
Cell & Gene Therapy
Biologics

4DMT enrols first patients in 4SIGHT Phase 3 DME gene therapy trial

4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
Biologics
Pharmaceuticals

ALX Oncology's evorpacept hits 63.6% ORR in HER2+ gastric subgroup

Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Medical Devices
Diagnostics
Digital Health

CapsoVision wins FDA clearance for AI Highlights capsule endoscopy tool

CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
Cell & Gene Therapy
Biologics

Currus Biologics wins FDA IND clearance for CUR-001 CAR-T trial

The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
The Australian biotech will begin a first-in-human Phase 1 basket study in mesothelin-positive solid tumours, with first patient dosing expected in early
Pharmaceuticals
Biologics

HUTCHMED files US NDA for savolitinib plus osimertinib in NSCLC

AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
AstraZeneca has submitted a US NDA for savolitinib plus osimertinib in MET-driven EGFR-mutated NSCLC, backed by Phase III PFS and OS data.
Bioprocessing
Pharmaceuticals

Lifecore Biomedical to go private in $664m Webster Equity deal

Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
Webster Equity Partners will acquire the CDMO for $6.28 per share in cash, plus CVRs worth up to $9.67 per share if performance
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.
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.
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova present Klothonova encapsulated-cell data

The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
The preclinical joint venture presented its α-Klotho cell-encapsulation programme at a Miami longevity conference, outlining progress on a GMP cell bank.
Digital Health

Ingenio Care launches AI-enabled national healthcare marketplace

The Illinois-based digital health company says its marketplace lists over 7.5 million US providers with CMS pricing and quality data.
The Illinois-based digital health company says its marketplace lists over 7.5 million US providers with CMS pricing and quality data.
Pharmaceuticals
Biologics
Diagnostics

ITM reports re-treatment and dosimetry data for ITM-11 at ASTRO

Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Real-world SwissNET registry data showed patients re-treated with 177Lu-edotreotide achieved nearly triple the median overall survival of those switched to
Medical Devices

Kessler Foundation and UPnRIDE partner on upright mobility study

Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
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.
Cell & Gene Therapy
Biologics

Celularity closes $10m first tranche of $28m recapitalisation

Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
Celularity has completed an initial $10m raise from convertible notes, targeting positive monthly operating cash flow by end of Q1 2027.
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
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