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 Rastogi4 days ago

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Innovent Reports the P-III (RESTORE-3) Study of Sycume in Inactive Thyroid Eye Disease

Shots: Innovent has reported the P-III (RESTORE-3) trial data assessing Sycume(teprotumumab N01/IBI311) vs PBO in Chinese pts (n=116) with inactive thyroid eye disease (bilateral CAS ≤ 2 points) Trial met its 1EP at Wk. 24, showing higher proptosis response rate as compared to PBO (60.4% vs. 23.5%), plus in 2EP, Sycume showed LS Mean change…

ByRidhi Rastogi4 days 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 Rastogi5 days 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 RastogiOctober 8, 2026

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Cerevance Reports the P-III (ARISE) Trial Data on Solengepras in Parkinson’s Disease

Shots: Cerevance has reported the P-III (ARISE) trial data assessing solengepras (75 or 150mg, QD, PO) vs PBO as an adjunct to levodopa & other PD medications in 341 PD pts (≥30yrs.) with motor fluctuations & ≥3hrs. of daily OFF time (91% pts completed the trial) Solengepras (150mg) met the 1EP, reducing average daily OFF time…

ByRidhi RastogiOctober 8, 2026

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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 RastogiOctober 8, 2026

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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 RastogiOctober 7, 2026

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Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

Shots: FDA granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic for treating negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, incl. antipsychotic therapy, in pts (≥18yrs.) with clinically stable positive symptoms Clearance was supported by the P-III (CONVOKE) trial assessing CT-155 vs a digital control app in pts (≥18yrs.) with…

ByRidhi RastogiOctober 7, 2026

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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 RastogiOctober 5, 2026

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Johnson & Johnson Reports P-III (ICONIC-TOTAL) Trial Data on Icotyde for Difficult-to-Treat Plaque Psoriasis

Shots: J&J has reported the 2yr. P-III (ICONIC-TOTAL) trial data assessing Icotyde vs PBO for the treatment of PsO in pts with at least moderate severity affecting special areas (e.g., scalp, genital, &/or hands and feet) Icotyde maintained durable skin clearance, with IGA 0/1 rates increasing from 57% at Wk. 16 to 67% at Wk.…

ByRidhi RastogiOctober 5, 2026

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

Innovent Reports the P-III (RESTORE-3) Study of Sycume in Inactive Thyroid Eye Disease

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

Cerevance Reports the P-III (ARISE) Trial Data on Solengepras in Parkinson’s Disease

Novartis’ Rhapsido Receives US FDA Approval for Symptomatic Dermographism

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

Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

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

Johnson & Johnson Reports P-III (ICONIC-TOTAL) Trial Data on Icotyde for Difficult-to-Treat Plaque Psoriasis

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