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Optum Rx Launches Industry's First Transparent Pharmacy Care Model
Optum Rx launches the industry’s first transparent pharmacy care model, improving drug pricing transparency, aligning incentives, and expanding affordability tools for patients and health plan sponsors.
Transpire Bio Secures FDA Filing Acceptance for Generic High-Strength Trelegy Ellipta ANDA
Transpire Bio receives US Food and Drug Administration (FDA) filing acceptance for its generic high-strength Trelegy Ellipta ANDA with Paragraph IV certification under the Hatch-Waxman Act.
Avid Bioservices Names Kerri McCullough Wood Chief Commercial Officer
Avid Bioservices appoints Kerri McCullough Wood as Chief Commercial Officer (CCO) to lead global commercial strategy and accelerate growth across early- and late-phase biologics programs.
Bristol Myers Squibb Secures EC Approval for Sotyktu in Psoriatic Arthritis
Bristol Myers Squibb receives European Commission (EC) approval for Sotyktu to treat active psoriatic arthritis in adults, marking the EU’s first approved TYK2 inhibitor for this indication.
Rznomics Secures US FDA RMAT Designation for Liver Cancer Gene Therapy Candidate RZ-001
The FDA has granted Regenerative Medicine Advanced Therapy designation to RZ-001, an RNA-based gene therapeutic for hepatocellular carcinoma, accelerating its clinical development and regulatory review pathway.
Hongene Biotech Supports SiranBio's Dual-Target siRNA Programme for Chronic Hepatitis B
Hongene Biotech provided end-to-end CDMO support for SiranBio’s SA1211 siRNA candidate, highlighting its capabilities in complex oligonucleotide therapeutic development and manufacturing.
Harbour BioMed Secures FDA IND Clearance for HBM7004 in Advanced Solid Tumors
Harbour BioMed receives US Food and Drug Administration (FDA) IND clearance for HBM7004, a novel B7H4xCD3 bispecific antibody developed on its HBICE platform for advanced solid tumors.
Mabwell Secures FDA Clearance for 9MW5211 Clinical Trial Application
Mabwell receives US Food and Drug Administration (FDA) IND clearance for 9MW5211, a novel antibody therapy being developed for Inflammatory Bowel Disease (IBD) clinical studies.
NIPER Raebareli Signs CDA and Tech Transfer Pact with Lofty Laboratories
NIPER Raebareli signs CDA and technology transfer agreement with Lofty Laboratories to advance indigenous technology commercialisation in biotechnology sector.
LEQEMBI IQLIK Subcutaneous Dose Gets US FDA Priority Review for Early Alzheimer's Disease
LEQEMBI IQLIK subcutaneous dose review by US Food and Drug Administration (FDA) extended after major sBLA amendment for early Alzheimer’s disease, with no approvability concerns raised.
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