Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

Shots: The US FDA has granted RMAT Designation to KB707 for the treatment of advanced or metastatic NSCLC Designation was supported by the ongoing P-I/II (KYANITE-1) trial assessing KB707 (administered via nebulization) across 7 cohorts: Arms 1-4 as monotx., Arm 5 with Keytruda, Arm 6 with Keytruda & CT & Arm 7 with CT alone…

ByRidhi RastogiFebruary 10, 2026

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Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Shots: The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26 NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…

ByRidhi RastogiFebruary 10, 2026

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Median Technologies Receives the US FDA’s 510(k) Clearance for eyonis LCS for Lung Cancer Detection and Diagnosis

Shots: The US FDA has granted 510(k) clearance to eyonis Lung Cancer Screening (LCS), an AI/ML-powered CADe/CADx software, to detect & diagnose lung cancer eyonis LCS analyzes LDCT imaging to help radiologists detect & characterize pulmonary nodules, enabling earlier diagnosis; in testing it showed 93.3% sensitivity, 92.4% specificity & 99.9% NPV, minimizing false positives &…

ByRidhi RastogiFebruary 9, 2026

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Pfizer Receives the US FDA Priority Review for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has accepted sBLA & granted priority review to Hympavzi for the treatment of pts (≥6yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B without inhibitors (PDUFA: Q2’26) sBLA for Hympavzi (SC, QW) in adults & adolescents was supported by data from the inhibitor…

ByRidhi RastogiFebruary 9, 2026

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Boehringer Ingelheim Secures US FDA’s EUA for Ivomec (ivermectin) to Prevent New World Screwworm Infestations in Cattle

Shots: The US FDA has granted Emergency Use Authorization for the use of Ivomec (ivermectin) 1% Injection for the prevention of infestations caused by New World screwworm (NWS) in cattle Under the EUA, Ivomec is authorized for NWS prevention when administered within 24hrs. of birth, at castration, or upon wound appearance, with specific exclusions for…

ByRidhi RastogiFebruary 6, 2026

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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

Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Median Technologies Receives the US FDA’s 510(k) Clearance for eyonis LCS for Lung Cancer Detection and Diagnosis

Pfizer Receives the US FDA Priority Review for Hympavzi to Treat Hemophilia A or B in Two Populations

Boehringer Ingelheim Secures US FDA’s EUA for Ivomec (ivermectin) to Prevent New World Screwworm Infestations in Cattle

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

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