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Systematic, data-driven science coverage · Thursday, October 8, 2026
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Regulatory & Policy

China Medical System's TYK2 inhibitor picks up China trial nod for ulcerative colitis and Crohn's disease

China Medical System Holdings [HKEX: 0867], headquartered in Hong Kong, has received clinical trial approval from China's National Medical Products...

May 26
Development

Kelun, Merck's sac-TMT plus Keytruda cuts progression risk by 65% in advanced NSCLC

Kelun-Biotech (6990.HK) is presenting Phase III data at ASCO 2026 showing that sacituzumab tirumotecan combined with Merck's Keytruda (pembrolizumab) cut...

May 26
Regulatory & Policy

Henlius Bio readies first-in-class EGFR/c-MET bispecific ADC for Phase I in China

Shanghai Henlius Biotech (HKEX: 2696) announced on May 21, 2026 that China's National Medical Products Administration has approved the investigational new...

May 26
Regulatory & Policy

Henlius advances STEAP1/CD3/ CD28 trispecific T-cell engager to Phase I in prostate cancer

Shanghai Henlius Biotech (HKEX: 2696) has received clearance to initiate a Phase I clinical trial of HLX3902, a trispecific T-cell engager antibody...

May 26
News

Lundbeck receives South Korean approval for Vyepti for preventive migraine treatment in adults

H. Lundbeck A/S has received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vyepti (eptinezumab; ALD403) for…

May 26
News

FDA grants accelerated approval to Gilead’s Hepcludex for chronic hepatitis delta virus infection

Gilead Sciences (Nasdaq: GILD) has received US FDA accelerated approval for Hepcludex (bulevirtide-gmod) for the treatment of chronic hepatitis delta virus (HDV)…

May 26
Regulatory & Policy

Shanghai Henlius puts B7H3 bifunctional fusion protein into Phase I testing for advanced solid tumours

Shanghai Henlius Biotech (HKEX: 2696) dosed the first patient in the HLX316 clinical trial, a Phase I first-in-human study evaluating the B7-H3-targeting...

May 26
Development

TreeFrog posts preclinical data for 3D neural microtissue therapy in Parkinson's disease

TreeFrog Therapeutics, a Bordeaux-based regenerative medicine biotech, reported preclinical data on TFG-001, its 3D neural microtissue cell therapy for...

May 26
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FDA expands Daiichi/AZ’s TROP2 ADC Datroway into first-line metastatic TNBC

The US FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate co-developed by Daiichi Sankyo and AstraZeneca, for adult patients with…

May 22
News

Agios secures Euro approval for Pyrukynd in thalassemia

Agios Pharmaceuticals (Nasdaq: AGIO) has received European Commission marketing authorization for Pyrukynd (mitapivat) in adults with anemia associated with transfusion-dependent and non-transfusion-dependent…

May 22
News

EMA recommends Novo Nordisk’s Wegovy pill for obesity

Novo Nordisk’s Wegovy pill (oral semaglutide 25 mg) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products…

May 22
Regulatory & Policy

CHMP backs tumor-agnostic EU use of Enhertu across HER2-positive solid tumors

Daiichi Sankyo and AstraZeneca's Enhertu receives CHMP recommendation for HER2-positive solid tumors in the EU

May 22
Development

Inovio's VGX-3100 meets primary endpoint in Phase III cervical dysplasia trial in China

ApolloBio, Inovio Pharmaceuticals' (Nasdaq: INO) Chinese partner, has announced that VGX-3100, a DNA immunotherapy targeting HPV16 and HPV18, met its...

May 22
Development

Swedish Orphan Biovitrum's pozdeutinurad meets primary endpoint in Phase III gout trial

Swedish Orphan Biovitrum (STO: SOBI) reported that both doses of pozdeutinurad met the primary endpoint in the Phase III REDUCE 2 study, with 69.2% of...

May 22
Development

Biogen and Denali's pull plug on LRRK2 inhibitor after Phase II failure in early Parkinson's

Biogen (Nasdaq: BIIB) and Denali Therapeutics (Nasdaq: DNLI) reported that BIIB122 (DNL151), a selective small-molecule LRRK2 inhibitor, failed to slow...

May 22