Regulation

Biologics
Regulatory Science

Novartis Fabhalta wins FDA traditional approval in IgA nephropathy

Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.

RapidPulse closes $48m Series B to advance TURBO stroke trial

The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
Biologics

Teva licenses Polpharma ocrelizumab biosimilar for global markets

Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
Biologics

Allogene ALLO-316 achieves 31% response rate in solid tumour Phase 1

Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Diagnostics

Alpha Tau treats first immunocompromised cSCC patient in ADMIRE trial

Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Biologics

Cellectar publishes Phase 1 iopofosine I 131 data in multiple myeloma

Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Biologics

InnoCare soficitinib meets Phase III endpoint in atopic dermatitis

InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
Biologics

ENDURANCE trial: two-year lenalidomide matches lifelong therapy

A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
Diagnostics
Biologics

IGeneX single-step immunoblot nearly doubles early Lyme detection rate

A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
Biologics

Novo Nordisk wins EC approval for Wegovy pill as EU's first oral GLP-1

The European Commission has approved once-daily oral semaglutide 25 mg for weight management, making Wegovy the first GLP-1 pill available across all EU
The European Commission has approved once-daily oral semaglutide 25 mg for weight management, making Wegovy the first GLP-1 pill available across all EU
Digital Health

KPMG UK leads Black Book 2026 NHS EPR consulting scorecard

Black Book ranked 20 NHS EPR consultants across 620 executive inputs, with KPMG UK/EPR Alliance topping the 18-criterion scorecard at 9.57.
Black Book ranked 20 NHS EPR consultants across 620 executive inputs, with KPMG UK/EPR Alliance topping the 18-criterion scorecard at 9.57.
Diagnostics
Digital Health

Brain & Performance Centre signs MOU with UAE Athletic Commission

The DP World-owned brain health facility will offer optional neurological assessments to professional boxers competing in sanctioned UAE events.
The DP World-owned brain health facility will offer optional neurological assessments to professional boxers competing in sanctioned UAE events.
Biologics

InnoCare's orelabrutinib cuts CLL/SLL progression risk by 68% in Phase 3

Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.
Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.

ORIC Pharmaceuticals starts Phase 3 Himalayas-1 trial in mCRPC

ORIC has dosed first patients in its 600-person global Phase 3 trial of rinzimetostat plus darolutamide, backed by a supply deal with Bayer.
ORIC has dosed first patients in its 600-person global Phase 3 trial of rinzimetostat plus darolutamide, backed by a supply deal with Bayer.
Biologics

Aligos receives $25m upfront as China HBV licence deal activates

Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
Aligos Therapeutics has received the first cash payment from its Greater China licence of HBV candidate pevifoscorvir sodium, which also secured China's Breakthrough
Biologics
Regulatory Science

Bavarian Nordic files chikungunya vaccine for approval in Brazil

Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
Biologics

Cadrenal Phase 2 data show 25% thrombotic event cut in HIT

CAD-1005 cut new thrombotic events by more than 25% versus placebo in the first randomised, blinded trial in heparin-induced thrombocytopenia.
CAD-1005 cut new thrombotic events by more than 25% versus placebo in the first randomised, blinded trial in heparin-induced thrombocytopenia.
Biologics
Regulatory Science

Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC

The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
Biologics

FDA clears lecanemab subcutaneous autoinjector for Alzheimer's

Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Eisai and Biogen's LEQEMBI IQLIK autoinjector gains FDA approval as an initiation dose, offering patients a home-use alternative to intravenous infusion.
Regulatory Science

Claria Medical wins FDA De Novo clearance for hysterectomy device

The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
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