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Opamtistomig Fast Track: three-stage chevron graphic from Phase I/IIa to Phase II to ESMO data
Posted inPharmaceutical

FDA Grants Fast Track Status to Leads Biolabs’ Opamtistomig in Biliary Tract Cancer

Opamtistomig Fast Track: FDA status for first-line biliary tract cancer, nine days after submission. What it means, the data so far and what ESMO may show.
October 13, 2026
Encaleret ADH1 Phase 3: dumbbell graphic comparing symptom improvement rates on encaleret versus standard of care
Posted inPharmaceutical

Encaleret Improves Symptoms and Bone Turnover in Phase 3 ADH1 Study

Encaleret ADH1 Phase 3: PTH recovered in 91% and more patients reported symptom gains, but group sizes, statistics and safety data were not disclosed.
October 13, 2026
Tovinontrine HFrEF Phase 2: dose tiles showing greatest NT-proBNP reduction at 2.5 mg and no benefit at 50 mg
Posted inPharmaceutical

Cardurion Reports Positive Phase 2 Results for Tovinontrine in HFrEF

Tovinontrine HFrEF Phase 2: lower doses cut NT-proBNP in 529 patients, but 50 mg did not, and HFpEF showed no change. What is proven and what is not.
October 13, 2026
ICP-B161 IND approval: Y-shaped bispecific antibody graphic binding TL1A and IL-23p19
Posted inPharmaceutical

InnoCare Wins China IND Approval for IBD Bispecific Antibody ICP-B161

ICP-B161 IND approval: China clears InnoCare’s TL1A and IL-23p19 bispecific antibody for trials in IBD. What the company claims and what is undisclosed.
October 13, 2026
CAMCEVI NMPA approval: timeline graphic showing six months between injections of the leuprolide depot
Posted inPharmaceutical

Foresee’s CAMCEVI Wins NMPA Approval in Advanced Prostate Cancer

CAMCEVI NMPA approval: China clears Foresee’s six-month leuprolide depot for advanced prostate cancer; GenSci to sell it. What is and is not known.
October 13, 2026
Grünenthal Asia-Pacific pain access: hub graphic linking DKSH to eight Asia-Pacific markets and a South Korea licence
Posted inPharmaceutical

Grünenthal Widens Asia-Pacific Pain Access Through DKSH and Korea Deals

Grünenthal Asia-Pacific pain access plan: DKSH to seek approvals for four medicines in eight markets, plus a Qutenza licence in South Korea. What is known.
October 13, 2026
SYCUME inactive thyroid eye disease: 60.4% responders versus 23.5% on placebo at week 24
Posted inPharmaceutical

Innovent Reports Phase 3 Success for SYCUME in Inactive Thyroid Eye Disease

SYCUME inactive thyroid eye disease: Innovent reports Phase 3 success, with 60.4% responders vs 23.5% on placebo at week 24 in RESTORE-3.
October 12, 2026
Deucrictibant HAE Phase 3: symptom relief at 1.28 hours and resolution at 11.95 hours on a 12-hour axis
Posted inPharmaceutical

Deucrictibant Shows Faster Symptom Relief in Phase 3 HAE Study, Published in The Lancet

Deucrictibant HAE Phase 3 RAPIDe-3 results in The Lancet: oral capsule showed symptom relief in 1.28 hours. FDA decision due April 2027.
October 12, 2026
Tecentriq stage III dMMR colon cancer: 36-month disease-free survival 86% versus 76% in the ATOMIC trial
Posted inPharmaceutical

FDA Approves Tecentriq Combination for Stage III dMMR Colon Cancer

Tecentriq stage III dMMR colon cancer approval: FDA clears atezolizumab plus chemotherapy, with 36-month disease-free survival of 86% vs 76%.
October 12, 2026
Graphic: FDA accepts Bayer KERENDIA sNDA for chronic kidney disease without diabetes, with FIND-CKD Phase 3 data chips
Posted inPharmaceutical

FDA Accepts Bayer KERENDIA Application for CKD Without Diabetes

The FDA accepted Bayer’s application to extend KERENDIA to adults with chronic kidney disease without diabetes. FIND-CKD results, risks and next steps.
October 9, 2026

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