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ZipBio and MeiraGTx Partner to Advance AAV Gene Therapy for Geographic Atrophy
Shots: ZipBio has entered into an exclusive license agreement with MeiraGTx, granting MeiraGTx exclusive right to AAV gene therapy to treat Geographic Atrophy Licensing deal will combine MeiraGTx’s expertise in vector design, clinical development, & in-house genetic medicine manufacturing with ZipBio’s de novo protein therapeutics created using its COMPACT generative AI platform As per the…
February 4, 2026
Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer
Shots: The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…
February 4, 2026
Saya Biologics and Kashiv BioSciences Partner to Introduce a Biosimilar Supportive Oncology Therapy in Mexico and the CAC Region 
Shots:  Saya Biologics has signed a strategic partnership with Kashiv BioSciences to register and commercialize a supportive oncology therapy in Mexico and the CAC region  As per the deal, the agreement spans 11 countries across Mexico and the CAC region. Saya Biologics will handle regulatory registration, commercialization, and distribution, while Kashiv BioSciences will oversee manufacturing and supply.   Saya has already submitted the regulatory dossier in Mexico,…
February 4, 2026
Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease
Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
February 4, 2026
Zonsen PepLib Biotech and Eli Lilly Partner to Advance Peptide-Based Therapies
Shots: Zonsen PepLib Biotech has entered into a worldwide R&D and license agreement with Eli Lilly to jointly advance peptide-based drug candidates using PepLib’s robust & diverse peptide libraries & discovery platforms As per the deal, PepLib will screen & identify optimal peptide molecules using its in-house platform, while Lilly will oversee IND-enabling activities, clinical…
February 4, 2026
Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)
Shots: The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026) NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…
February 3, 2026
Astrazeneca and Daiichi-Sankyo New
Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26) sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…
February 3, 2026
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