The US FDA Approves UCB’s Zilbrysq Autoinjector for Self-Administration in AChR+ gMG

Shots: The US FDA has approved UCB’s Zilbrysq (zilucoplan) autoinjector for once-daily self-administration in adults with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive, adding to the existing prefilled syringe option Supportive data incl. P-I (DV0012) bioequivalence vs PFS in healthy volunteers (n=14) and P-IIIb (DV0013) in adults with gMG (n=31), where complete dose…

ByShivam Singh5 hours ago

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Revolution Medicines Receives the CHMP’s Positive Opinion for Rasonque (Daraxonrasib) to Treat Previously Treated Metastatic Pancreatic Adenocarcinoma

Shots: The EMA’s CHMP has adopted a positive opinion recommending marketing authorization of Revolution Medicines’ Rasonque (daraxonrasib) once-daily oral tablets as monotherapy for adults with metastatic pancreatic adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy; if approved by the EC, it would be the first broad RAS-targeted treatment option in the EU for these…

ByShivam Singh11 hours ago

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Edesa Biotech Receives the US FDA’s IND Clearance for P-II Study of EB06 to Treat Vitiligo

Shots: The US FDA has cleared Edesa Biotech’s IND application for its P-II study of EB06 in vitiligo, enabling expansion of recruitment to the US; recruitment is underway in Canada, with the first US sites expected to begin enrolling next quarter and topline data anticipated in Q4’27 The double-blind, PBO-controlled study is evaluating EB06 vs…

ByShivam Singh11 hours ago

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Elevar Therapeutics Resubmits US FDA NDA for Camrelizumab + Rivoceranib to Treat 1L uHCC

Shots: The US FDA has received the resubmitted NDA for rivoceranib + camrelizumab for the 1L systemic treatment option for unresectable or metastatic hepatocellular carcinoma (uHCC) Following an FDA Complete Response Letter in Jul 2026 for its Jan NDA submission, Elevar Therapeutics resubmitted the NDA on October 9, 2026, after working with the FDA and…

ByRidhi Rastogi1 day 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 Rastogi4 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 RastogiOctober 9, 2026

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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 RastogiOctober 9, 2026

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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

The US FDA Approves UCB’s Zilbrysq Autoinjector for Self-Administration in AChR+ gMG

Revolution Medicines Receives the CHMP’s Positive Opinion for Rasonque (Daraxonrasib) to Treat Previously Treated Metastatic Pancreatic Adenocarcinoma

Edesa Biotech Receives the US FDA’s IND Clearance for P-II Study of EB06 to Treat Vitiligo

Elevar Therapeutics Resubmits US FDA NDA for Camrelizumab + Rivoceranib to Treat 1L uHCC

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

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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