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Astrazeneca & Daiichi Sankyo
NEWS

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

Shots: The US FDA has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in mOS & 43% reduction in disease…
May 25, 2026

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Gilead
NEWS

Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Shots: The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up Trial showed significant improvements in HDV RNA reduction & ALT…
May 25, 2026

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Boehringer Ingelheim
NEWS

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The NMPA has granted conditional approval to Hernexeos (zongertinib) for initial treatment of adults with unresectable, locally advanced, or metastatic NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations Approval was based on the data from a treatment-naïve cohort (N=74) of P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75.7% (10.8%…
May 22, 2026

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NEWS

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…
May 22, 2026

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GSK
NEWS

GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…
May 19, 2026

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Bayer
NEWS

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…
May 19, 2026

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Astrazeneca
NEWS

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension  Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension  Trial met…
May 18, 2026

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NEWS

Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…
May 18, 2026

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Astrazeneca & Daiichi Sankyo
NEWS

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications

Shots: FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo For neoadj. setting, approval was backed by DESTINY-Breast11…
May 18, 2026

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