Zydus and Formycon Report the US FDA BLA Acceptance for FYB206 (Biosimilar, Keytruda)

Shots: The US FDA has accepted the BLA for FYB206, a biosimilar version of Keytruda (pembrolizumab), with FDA decision expected in the Q3’27. Regulatory dossier has also been submitted to Health Canada FYB206’sBLA acceptance has triggered a milestone payment from Zydus to Formycon, under their Dec 2025 exclusive licensing and supply agreement for the US…

ByRidhi Rastogi14 hours ago

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Mirum Reports Topline P-III (EXPAND) Trial Data on Livmarli (Maralixibat) in Ultra-Rare Cholestatic Liver Diseases

Shots: The P-III (EXPAND) trial assessed Livmarli (285µg/kg, BID,PO) vs PBO for cholestatic pruritus in pts (≥6mos.; n=52: 6 adults & 46 pediatric) with ultra-rare cholestatic liver diseases, incl. biliary atresia (BA), achieving statistically significance across all 5 EPs In the pediatric population, Livmarli improved pruritus severity (ItchRO(Obs): −1.81 vs −0.83) & increased days with…

ByRidhi Rastogi19 hours ago

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Genentech Reports P-III (MEERKAT & SANDCAT) Trial Data on Vamikibart in Uveitic Macular Edema (UME)

Shots: Genentech has reported the 1yr. data from the P-III (MEERKAT & SANDCAT) trials assessing vamikibart (intravitreal; 0.25 or 1mg, Q4W) vs a sham procedure for ~16wks. in adults with UME, followed by PRN treatment through wk. 52 At 52wks., trial showed numerically greater vision gains in both trials (1EP), with sustained improvements in BCVA…

ByRidhi Rastogi2 days ago

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Teva’s Weltruza Wins FDA Approval as a Once-Monthly SC Olanzapine Injection for Schizophrenia

Shots: The US FDA has approved Weltruza (olanzapine) for extended-release injectable suspension (QM, SC long-acting injectable) for the treatment of schizophrenia in adults, with availability expected in coming wks. Trial showed that Weltruza improved schizophrenia symptoms (PANSS), illness severity (CGI-S), and personal & social functioning. It will be available in 318, 425 & 531mg doses without loading…

ByRidhi Rastogi2 days ago

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Asahi Kasei Reports FDA Approval of Hovilpri for Mucocutaneous HSV Lesions in Immunocompromised Adults

Shots: The US FDA has approved Hovilpri (pritelivir; 100mg, PO) for treating acyclovir, valacyclovir or famciclovir-refractory mucocutaneous herpes simplex virus (HSV) lesions, with or without documented resistance, in immunocompromised adults. Launch is expected by the end of 2026 Approval was supported by the Part C of P-III (PRIOH-1) trial assessing Hovilpri (400mg loading dose on…

ByRidhi Rastogi2 days ago

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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 Rastogi5 days 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 Rastogi5 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 RastogiOctober 8, 2026

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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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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

Zydus and Formycon Report the US FDA BLA Acceptance for FYB206 (Biosimilar, Keytruda)

Mirum Reports Topline P-III (EXPAND) Trial Data on Livmarli (Maralixibat) in Ultra-Rare Cholestatic Liver Diseases

Genentech Reports P-III (MEERKAT & SANDCAT) Trial Data on Vamikibart in Uveitic Macular Edema (UME)

Teva’s Weltruza Wins FDA Approval as a Once-Monthly SC Olanzapine Injection for Schizophrenia

Asahi Kasei Reports FDA Approval of Hovilpri for Mucocutaneous HSV Lesions in Immunocompromised Adults

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

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