StimLabs Reports the US FDA 510(k) Clearance of Theracor for Acute and Chronic Wound Management

Shots: The FDA has granted 510(k) clearance to Theracor, a human umbilical cord-derived medical device offered in sheet form, for wound care Indicated for the same wound types as StimLabs’ Corplex P, Theracor is used for partial & full-thickness wounds, pressure, venous, diabetic, & chronic vascular ulcers, tunneled/undermined wounds, surgical sites, trauma-related injuries, & draining…

ByRidhi RastogiDecember 30, 2025

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INOVIO Reports the US FDA’s BLA Acceptance of INO-3107 for Recurrent Respiratory Papillomatosis (RRP)

Shots: The US FDA has accepted BLA of INO-3107 for the treatment for adults with RRP, granting PDUFA target action date of Oct 30, 2026 INOVIO filed a BLA for INO-3107 under the accelerated approval pathway & plans to engage with the FDA to align on requirements, while confirming it is not pursuing approval under…

ByRidhi RastogiDecember 30, 2025

NEWS

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Shots: The US FDA has granted BTD to ulixacaltamide for the treatment of patients with essential tremor (ET) Designation was based on the topline data from the Essential3 program, consisting of Study 1 & 2, where in Study 1, ulixacaltamide improved mADL11 (1EP) by 4.3 points at Wk. 8, while Study 2 showed superior maintenance of…

ByRidhi RastogiDecember 30, 2025

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Mereo BioPharma Reports P-III (ORBIT & COSMIC) Trials Findings on Setrusumab in Osteogenesis Imperfecta

Shots: Mereo BioPharma has reported setrusumab (UX143) results from the global P-III (ORBIT) trial vs PBO & P-III (COSMIC) trial vs bisphosphonates (IV) in 159 pts (5-25yrs.) & 69 pts (2 to <7 yrs.), respectively, with osteogenesis imperfecta Neither study met its 1EP of reduced annualized clinical fracture rate, but both showed statistically significant improvements…

ByRidhi RastogiDecember 30, 2025

NEWS

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

Shots: The Chinese NMPA has approved neffy 2mg for the emergency treatment of type I allergic reactions (anaphylaxis) in adults & children (≥30kg), with availability anticipated in the spring of 2026. Filing for neffy 1mg for children (15 to <30kg) to the NMPA is expected in the coming mos. In 2021, ARS Pharma licensed neffy…

ByRidhi RastogiDecember 30, 2025

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Adlai Nortye Licenses AN9025 to ASK Pharm in a ~$230M Deal

Shots: Adlai Nortye has granted ASK Pharm exclusive rights to develop, manufacture, & commercialize AN9025 in mainland China, Hong Kong & Macao, with Adlai retaining rights in other regions As per the deal, Adlai will receive ~$230M, incl. >$20M in upfront & near-term milestone, plus tiered royalties ranging from a high single-digit to mid-teens %…

ByRidhi RastogiDecember 29, 2025

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HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Shots: The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapy NDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, …

ByRidhi RastogiDecember 29, 2025

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Transcenta and EirGenix Collaborate to Advance Integrated Continuous Biomanufacturing Technologies

Shots: EirGenix has entered into a strategic collaboration and non-exclusive licensing agreement with Transcenta for its Highly Intensified Continuous Bioprocessing (HiCB) platform Under the agreement, Transcenta will grant EirGenix a non-exclusive license to its HiCB platform, incl. continuous perfusion & integrated hybrid continuous purification process technologies, as well as documentation, know-how & regulatory support to…

ByRidhi RastogiDecember 29, 2025

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CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Shots: Chinese NMPA received two IND applications for CT0596 to initiate P-Ib/II trials in r/r multiple myeloma (MM) & primary plasma cell leukemia (pPCL), respectively IIT in China showed favorable efficacy as of Aug 31, 2025, with 6/8 evaluable R/R MM pts achieving PR or better (3 CR/sCR, 1 VGPR, 2 PR) at an mFU…

ByRidhi RastogiDecember 29, 2025

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Harbour BioMed Collaborates with Yantai Lannacheng Biotechnology to Develop Radionuclide Drug Conjugates (RDCs)

Shots: Harbour BioMed has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology to jointly advance the development of next-generation RDCs Collaboration will combine Harbour’s fully human antibody discovery capabilities via its Harbour Mice platform with Lannacheng’s radiopharmaceutical R&D & commercialization strengths Harbour Mice platform provides fully human mAbs in both conventional & heavy chain-only…

ByRidhi RastogiDecember 29, 2025

Ridhi Rastogi

StimLabs Reports the US FDA 510(k) Clearance of Theracor for Acute and Chronic Wound Management

INOVIO Reports the US FDA’s BLA Acceptance of INO-3107 for Recurrent Respiratory Papillomatosis (RRP)

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Mereo BioPharma Reports P-III (ORBIT & COSMIC) Trials Findings on Setrusumab in Osteogenesis Imperfecta

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

Adlai Nortye Licenses AN9025 to ASK Pharm in a ~$230M Deal

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Transcenta and EirGenix Collaborate to Advance Integrated Continuous Biomanufacturing Technologies

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Harbour BioMed Collaborates with Yantai Lannacheng Biotechnology to Develop Radionuclide Drug Conjugates (RDCs)

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