Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Shots: The US FDA has approved AptimaHPV Assay, an mRNA-based assay for clinician-collected HPV primary screening Approval follows completion of a real-world HPV screening study of 650,000+ women across US, showing the Aptima HPV Assay has clinically comparable sensitivity to an FDA-approved DNA-based HPV test & is effective for detecting CIN2+ & CIN3+ in primary…

ByRidhi RastogiFebruary 5, 2026

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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…

ByRidhi RastogiFebruary 4, 2026

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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,…

ByRidhi RastogiFebruary 4, 2026

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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)…

ByRidhi RastogiFebruary 3, 2026

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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…

ByRidhi RastogiFebruary 3, 2026

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Novo Nordisk Reports P-III (REIMAGINE 2) Trial Data on CagriSema for Type 2 Diabetes

Shots: The P-III trial evaluated CagriSema (SC; QW), a fixed-dose combination of cagrilintide & semaglutide, at two dose levels (2.4mg/2.4mg & 1mg/1mg) vs semaglutide (2.4 & 1mg), cagrilintide (2.4mg) alone, & PBO in 2,728 pts with T2D inadequately controlled with metformin ± an SGLT2 inhibitor At 68wks., CagriSema (2.4/2.4mg) outperformed semaglutide (2.4mg), reducing HbA1c by…

ByRidhi RastogiFebruary 3, 2026

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Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…

ByRidhi RastogiFebruary 2, 2026

NEWS

Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026) BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who…

ByRidhi RastogiJanuary 30, 2026

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Tenpoint Therapeutics Reports the US FDA Approval of Yuvezzi to Treat Presbyopia

Shots: The US FDA has approved Yuvezzi (carbachol & brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, for the treatment of presbyopia in adults; commercially available by Q2’26 Approval was backed by 2 P-III (BRIO I & BRIO II) trials (n>800), with BRIO I showing superior benefit vs individual actives & BRIO II…

ByRidhi RastogiJanuary 29, 2026

NEWS

Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

Shots: The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…

ByRidhi RastogiJanuary 29, 2026

Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

Novo Nordisk Reports P-III (REIMAGINE 2) Trial Data on CagriSema for Type 2 Diabetes

Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Tenpoint Therapeutics Reports the US FDA Approval of Yuvezzi to Treat Presbyopia

Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

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