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Development

China's SmartNuclide puts GPA33-directed pretargeted radioimmunotherapy into Phase I for CRC

A first-in-human trial of SNA028, a two-step pretargeted radioimmunotherapy targeting the GPA33 antigen, has been registered at Tianjin Medical University...

May 19
Regulatory & Policy

FDA accepts Viatris's NDA for MR-107A-02 fast-acting meloxicam for acute pain

Viatris (Nasdaq: VTRS) has submitted a New Drug Application (NDA) to the US FDA for MR-107A-02 (fast-acting meloxicam), an investigational oral...

May 19
Development

CSPC's tissue factor-targeting ADC enters Phase I for advanced solid tumors

CSPC Pharmaceutical Group (HKEX: 1093) has initiated a first-in-human Phase I clinical trial of SYS6051, a tissue factor (TF)-targeting antibody-drug...

May 19
Development

Cellio Therapeutics' iPSC-derived retinal pigment epithelium C.001 enters Phase I for RPE-mediated maculopathy

Cellio Therapeutics has opened a first-in-human Phase I trial of C.001, an autologous iPSC-derived retinal pigment epithelium cell therapy, in adults with...

May 19
Development

Mestag's FAP-targeted lymphotoxin agonist aims to engineer tertiary lymphoid structures in cold tumors

Mestag Therapeutics, a Cambridge, UK-based clinical-stage biotech, has dosed the first patient in the STARLYS trial, a Phase I study evaluating MST-0312, a...

May 19
Development

Relay Therapeutics' zovegalisib achieves 60% response rate in Phase II PIK3CA vascular anomalies trial

Relay Therapeutics (Nasdaq: RLAY) has reported initial zovegalisib clinical data from the Phase II ReInspire trial in PIK3CA-driven vascular anomalies,...

May 19
News

Japan approves Boehringer Ingelheim’s Jascayd for idiopathic and progressive pulmonary fibrosis

Boehringer Ingelheim’s Jascayd (nerandomilast) receives approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with idiopathic…

May 19
Development

iECURE's ECUR-506 achieves 57% reduction in hyperammonemic events in OTC deficiency trial

iECURE reported statistically significant reductions in hyperammonemic events from the ECUR-506 OTC-HOPE trial, with the completed low-dose cohort showing a...

May 19
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Development

AeroRx posts positive Phase II data for nebulized LABA/LAMA drug in COPD

AeroRx Therapeutics has reported Phase 2a data for AERO-007, a nebulized fixed-dose combination of indacaterol and glycopyrrolate, showing statistically...

May 19
News

Enveric secures US patent for non-hallucinogenic psilocybin derivatives treating psychiatric disorders

Enveric Biosciences (Nasdaq: ENVB), headquartered in Cambridge, Massachusetts, announced receipt of US Patent No. 12,605,361 from the USPTO on April 21, 2026,…

May 19
News

Bayer’s asundexian Factor XIa inhibitor receives FDA Priority Review for secondary stroke prevention

Bayer (XETRA: BAYN) announced that the US FDA has accepted its New Drug Application (NDA) and granted Priority Review designation for asundexian…

May 19
Business

Gossamer Bio exchanges USD 120m convertible debt to stabilize balance sheet ahead of seralutinib PAH filing

San Diego-based Gossamer Bio (Nasdaq: GOSS) has announced an exchange offer and concurrent consent solicitation targeting more than USD 120 million of its...

May 19
Business

Hansa Biopharma licenses Europe, MENA rights for Idefirix to SERB Pharmaceuticals for EUR 115m

Hansa Biopharma (Nasdaq Stockholm: HNSA), the Lund, Sweden-based biopharmaceutical company, has licensed European and MENA commercialization rights for...

May 19
News

ImmunityBio secures five US patents for ANKTIVA plus BCG bladder cancer therapy through 2035

ImmunityBio (Nasdaq: IBRX), headquartered in Culver City, California, has received five issued US patents covering the combination of its IL-15 receptor agonist…

May 18
Development

Nanobiotix's JNJ-1900 produces strong early Phase II data in stage III lung cancer

Nanobiotix (Euronext: NANO; Nasdaq: NBTX) reported an 85.7% overall response rate and a 57.1% complete response rate in seven patients with stage III...

May 18