AbbVie Secures EC Approval for Rinvoq to Treat Non-Segmental Vitiligo

Shots: The EC has approved Rinvoq (upadacitinib; 15mg, QD) for the treatment of pts (≥12yrs.) with non-segmental vitiligo (NSV) who are candidates for systemic therapy Approval was backed by the Viti-Up clinical program (M19-044; n=614), incl. 2 replicate trials assessing Rinvoq, where in Period A, pts were randomized to either Rinvoq or PBO for 48wks. &…

ByRidhi RastogiJuly 29, 2026

NEWS

Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Shots: The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026 Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to…

ByRidhi RastogiJuly 29, 2026

NEWS

Elevation Spine Receives US FDA Clearance for Saber-C AVIA

Shots: The US FDA has granted 510(k) clearance to Saber-C AVIA, a zero-profile ACDF system featuring a porous 3D-printed titanium interbody with spike & screw fixation options Saber-C AVIA is designed to deliver the biomechanical stability of traditional plating in a lower-profile implant, featuring updated spike delivery tools, low-profile screw instruments, and a single-tray system…

ByRidhi RastogiJuly 29, 2026

NEWS

CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Shots: CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…

ByRidhi RastogiJuly 29, 2026

NEWS

Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Shots: The US FDA has granted IND clearance to initiate a P-I multiple ascending dose trial assessing DYNE-302 against PBO in ambulatory adults with facioscapulohumeral muscular dystrophy (FSHD) In the first cohort, 9 pts will receive DYNE-302 (1.5 mg/kg, Q4W) or PBO, with higher doses & less frequent dosing planned. Pts completing the PBO-controlled phase…

ByRidhi RastogiJuly 28, 2026

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Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

Shots: Hansoh has reported P-III (ARTEMIS-011) trial data assessing risvutatug rezetecan (HS-20093), a B7-H3–directed ADC, vs CT in pts with osteosarcoma who had progressed or relapsed after receiving ≥2 prior lines of systemic therapy Trial met its 1EP of improved PFS as assessed by the IRC, with consistent benefits observed across 2EPs, incl. OS & investigator-assessed…

ByRidhi RastogiJuly 28, 2026

NEWS

CSL Reports P-IIIb Trial Data on Andembry for HAE

Shots: CSL has reported topline P-IIIb results evaluating Andembry (garadacimab-gxii) in children aged 2 to 11yrs. with hereditary angioedema (HAE) Pts aged 6–11 years received 100mg (QM, n=16), while those aged 2–5yrs. received 100mg (Q2M, n=6). Andembry showed a favorable safety profile & treatment response, with most pts remaining attack-free over 12mos. Full results will be…

ByRidhi RastogiJuly 28, 2026

NEWS

Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

Shots: Akeso has dosed the first patient in the P-Ib/II (AK138D1-201) trial assessing AK138D1, as monotx. or in combination with ivonescimab for advanced NSCLC The study will evaluate the regimen across multiple settings in advanced NSCLC, incl. 1L treatment, treatment after EGFR-TKI resistance, & treatment after immuno-CT resistance AK138D1 is a HER3-targeted ADC comprising a…

ByRidhi RastogiJuly 28, 2026

NEWS

InnoCare Reports P-III Trial Findings on Fadeucravacitinib in Plaque Psoriasis

Shots: InnoCare has reported a P-III trial assessing the efficacy, safety & tolerability of fadeucravacitinib (ICP-488) vs PBO in pts with moderate-to-severe plaque psoriasis Trial met its 1EP with statistically significant & clinically meaningful improvement, while also achieving multiple 2EPs, demonstrating consistent efficacy across measures; data to be presented & published in the future Fadeucravacitinib…

ByRidhi RastogiJuly 28, 2026

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ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

Shots: ViiV has reported P-IIIb (VOGUE) study data assessing Dovato (DTG/3TC; n=254) vs Biktarvy (BIC/FTC/TAF; n=255) in 509 treatment-naïve adults living with HIV-1, where treatment was initiated before the availability of baseline resistance testing results At baseline, 47% pts had HIV-1 RNA ≥100,000 copies/mL, 16% had ≥500,000 copies/mL, & 16% had CD4+ counts <200 cells/mm³. At Wk.…

ByRidhi RastogiJuly 28, 2026

Ridhi Rastogi

AbbVie Secures EC Approval for Rinvoq to Treat Non-Segmental Vitiligo

Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Elevation Spine Receives US FDA Clearance for Saber-C AVIA

CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

CSL Reports P-IIIb Trial Data on Andembry for HAE

Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

InnoCare Reports P-III Trial Findings on Fadeucravacitinib in Plaque Psoriasis

ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

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