Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Shots: The NMPA has accepted BLA of Everest's Lerochol (lerodalcibep; SC, QM) as an adjunct to diet & exercise to reduce LDL-C in adults with hypercholesterolemia, incl. heterozygous familial hypercholesterolemia; regulatory review is ongoing in the EU The BLA was supported by multiple global trials & a P-III China study, where in global trials, Lerochol…

ByRidhi Rastogi4 hours ago

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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 RastogiJune 17, 2026

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Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Shots: The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…

ByRidhi RastogiJune 8, 2026

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Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Shots: The US FDA has accepted the resubmitted BLA for Xbrane's Lucamzi, a biosimilar to Lucentis, & assigned a BsUFA action date of Oct 29, 2026 The resubmission, completed in Apr 2026, addressed issues identified in the CRL received from the FDA in Oct 2025 The product is already approved & marketed in EU as…

ByRidhi RastogiJune 4, 2026

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Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept) Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

ByRidhi RastogiJune 4, 2026

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MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Shots: MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…

ByRidhi RastogiMay 15, 2026

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SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Shots: SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progression Trial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along…

ByRidhi RastogiApril 14, 2026

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Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

Shots: FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026) BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in…

ByRidhi RastogiApril 14, 2026

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DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

Shots: China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…

ByPrince GiriApril 10, 2026

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The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

Shots: The US FDA has accepted the resubmitted BLA of UX111 (rebisufligene etisparvovec) for accelerated approval in Sanfilippo syndrome Type A (MPS IIIA), with a PDUFA action date of Sep 19, 2026 UX111 BLA is supported by up to 8yrs. of follow-up data showing durable clinical benefit & acceptable safety. Also, during prior late-cycle review,…

ByRidhi RastogiApril 6, 2026

Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

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

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

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