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Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Drug Approval | January 08, 2026

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations


Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy
News | January 08, 2026

Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy

REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS


Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
Clinical Trials | January 08, 2026

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety


ICMR & Panacea Biotec complete enrollment for India's first indigenous dengue vaccine phase 3 study
Clinical Trials | January 08, 2026

ICMR & Panacea Biotec complete enrollment for India's first indigenous dengue vaccine phase 3 study

DengiAll will be the first indigenous single-shot dengue vaccine in India and is expected to enter the markets by 2027


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


ProBioGen, Zag Bio seal manufacturing deal to fast-track type 1 diabetes therapy into clinic
Biotech | January 07, 2026

ProBioGen, Zag Bio seal manufacturing deal to fast-track type 1 diabetes therapy into clinic

The work will leverage ProBioGen’s CHO.RiGHT expression platform, powered by its proprietary DirectedLuck transposase technology, alongside PsiBot smart automation


FDA grants priority review to Tzield for youngest Type 1 diabetes patients
Drug Approval | January 07, 2026

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D


Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma
News | January 07, 2026

Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma

Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide


Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China
Biopharma | January 07, 2026

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001


Subcutaneous Saphnelo cuts lupus disease activity in phase III trial
Biopharma | January 07, 2026

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage