Inhibrx Biosciences Reports the US FDA’s BLA Acceptance of Ozekibart to Treat Conventional Chondrosarcoma

Shots: The US FDA has accepted BLA of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, with no filing review issues identified yet (PDUFA: Apr 14, 2027) BLA was backed by the ChonDRAgon study assessing ozekibart vs PBO in pts with metastatic or unresectable conventional chondrosarcoma, which met its 1EP…

ByRidhi Rastogi11 hours ago

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The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Shots: The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027) sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…

ByRidhi Rastogi2 days ago

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AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26 sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…

ByRidhi Rastogi3 days ago

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Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…

ByRidhi Rastogi3 days ago

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AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…

ByRidhi Rastogi3 days ago

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Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…

ByRidhi RastogiJune 12, 2026

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NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Shots: The NMPA has accepted IND application for HBM7004 for the treatment of advanced solid tumors HBM7004, developed using Harbour’s HBICE platform, is a novel B7H4×CD3 bispecific antibody that is designed to enhance cancer immunotherapy, aiming to improve both efficacy & safety through targeted immune activation In preclinical studies, HBM7004 induced B7H4-dependent T-cell activation within…

ByRidhi RastogiJune 10, 2026

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Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Shots: The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…

ByRidhi RastogiJune 10, 2026

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Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots: The Chinese NMPA has approved Zai lab's Tivdak for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after CT Approval was backed by the global P-III (innovaTV 301) trial evaluating Tivdak vs CT alone, which met its 1EP of improved OS in the IIT population In the…

ByRidhi RastogiJune 9, 2026

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Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…

ByRidhi RastogiJune 9, 2026

Inhibrx Biosciences Reports the US FDA’s BLA Acceptance of Ozekibart to Treat Conventional Chondrosarcoma

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

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