Vir Biotechnology Secures the US FDA Fast Track Designation for VIR-5500 to Treat Prostate Cancer

Shots: The US FDA has granted Fast Track designation to VIR-5500 for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC) VIR-5500 is being evaluated in a P-I study across 6 dose-expansion cohorts, incl. monotx. in taxane-naïve, radioligand therapy-naïve & radioligand therapy-exposed mCRPC, & combinations with enzalutamide or docetaxel in early-line mCRPC, or darolutamide in…

ByRidhi Rastogi4 hours ago

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The US FDA Approves Genentech’s Tecentriq Combination for Stage III dMMR Colon Cancer

Shots: The US FDA has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) with fluoropyrimidine & oxaliplatin for the adj. treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer Approval was based on the P-III (ATOMIC) trial in above-mentioned pts (n=712), which were randomized to either mFOLFOX6 plus Tecentriq for 12 cycles…

ByRidhi Rastogi6 hours ago

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Bayer Reports US FDA sNDA Acceptance for Kerendia to Treat Non-Diabetic CKD

Shots: The US FDA has accepted sNDA of Kerendia (finerenone) for the treatment of adults with chronic kidney disease (CKD) without diabetes sNDA was supported by the P-III (FIND-CKD) trial assessing Kerendia (10 or 20mg) vs PBO, both on top of maximum tolerated labeled doses of a RAS-blocking therapy, in >1,500 adults with non-diabetic CKD …

ByRidhi Rastogi1 day ago

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The US FDA Approves Pfizer’s Tukysa as 1L Maintenance Treatment for HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Tukysa + trastuzumab & pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2+ breast cancer following induction treatment Approval was supported by the P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy…

ByRidhi Rastogi1 day ago

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Novartis’ Rhapsido Receives US FDA Approval for Symptomatic Dermographism

Shots: The US FDA has approved Rhapsido (remibrutinib) for the treatment of adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines Approval was based on SD cohort data of the P-III (RemIND) trial, where Rhapsido (PO) showed higher rates of complete response from hives at Wk. 12 vs PBO as measured by the Total…

ByRidhi Rastogi1 day ago

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BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Shots: The US FDA has accepted NDA & granted Priority Review to infigratinib (PO) for the treatment of children with achondroplasia (PDUFA: Feb 4, 2027). BridgeBio is prepared to launch infigratinib upon approval Trial met its 1EP, with infigratinib improving annualized height velocity at Wk. 52 (mean treatment difference: +2.10cm/yr.) & its key 2EP of…

ByRidhi Rastogi2 days ago

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Abbott Receives FDA Approval for New CardioMEMS HF System Patient-Facing Capabilities

Shots: Abbott received US FDA approval for updates to the CardioMEMS HF System, enabling patients in the US to view their pulmonary artery pressure (PAP) readings through the CardioGuide HF App The updated system includes Dynamic Treatment Plan (DTP), allowing care teams to create personalized medication adjustment plans based on changes in PAP and send…

ByPrince Giri3 days ago

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The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

Shots: The US FDA has approved an additional indication for Jaypirca (pirtobrutinib, 100 & 50mg) for the treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion Approval was based on the P-III (BRUIN CLL-313) trial data P-III assessing Jaypirca (200mg, PO, QD until disease progression…

ByRidhi Rastogi4 days ago

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BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Camzyos (mavacamten) for the treatment of symptomatic oHCM to improve functional capacity & symptoms in adults & pediatric pts (≥30kg) Approval was based on P-III (SCOUT-HCM) trial data assessing Camzyos (n=23) vs PBO (n=21) in 44 pts (12 to <18yrs.) with symptomatic NYHA class II-III oHCM, which met its 1EP,…

ByRidhi RastogiOctober 1, 2026

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Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Shots: The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…

ByRidhi RastogiOctober 1, 2026

Vir Biotechnology Secures the US FDA Fast Track Designation for VIR-5500 to Treat Prostate Cancer

The US FDA Approves Genentech’s Tecentriq Combination for Stage III dMMR Colon Cancer

Bayer Reports US FDA sNDA Acceptance for Kerendia to Treat Non-Diabetic CKD

The US FDA Approves Pfizer’s Tukysa as 1L Maintenance Treatment for HER2+ Metastatic Breast Cancer

Novartis’ Rhapsido Receives US FDA Approval for Symptomatic Dermographism

BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Abbott Receives FDA Approval for New CardioMEMS HF System Patient-Facing Capabilities

The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

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