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NEWS

Ascendis Pharma’s TransCon CNP (Navepegritide) Receives the CHMP’s Positive Opinion for Achondroplasia in Children

Shots: The CHMP has adopted a positive opinion recommending EU marketing authorization for Ascendis Pharma’s once-weekly TransCon CNP (navepegritide) for achondroplasia in children aged ≥2yrs. whose epiphyses are not closed; the EC decision on the MAA is expected in Q4’26 The opinion followed review of the MAA, incl. clinical data from 3 randomized, double-blind, PBO-controlled…
6 hours ago

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Ionis & Sobi
NEWS

Sobi and Ionis’ Tryngolza (Olezarsen) Receives the CHMP’s Positive Opinion for Severe Hypertriglyceridemia (sHTG)

Shots: The CHMP has adopted a positive opinion recommending the indication extension of Sobi’s Tryngolza (olezarsen) as an adjunct to diet, in combination with other lipid-lowering therapies, for adults with severe hypertriglyceridemia (sHTG; fasting TG ≥880 mg/dL [≥10 mmol/L]); if confirmed, it would be the first & only RNA-targeted therapy authorised in the EU for…
6 hours ago

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NEWS

Johnson & Johnson’s Talvey (Talquetamab) + Daratumumab Receives the CHMP’s Positive Opinion for Relapsed/Refractory Multiple Myeloma

Shots: The CHMP has recommended approval of an indication extension for Johnson & Johnson’s Talvey (talquetamab) + daratumumab ± pomalidomide for adults with relapsed/refractory multiple myeloma (RRMM) who have received ≥1 prior therapy; if approved, it will be the only GPRC5D-targeting bispecific antibody combination for RRMM as early as 2L Recommendation was based on the…
6 hours ago

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UCB
NEWS

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…
12 hours ago

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Revolution Medicines
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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…
18 hours ago

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NEWS

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…
5 days ago

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NEWS

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…
October 9, 2026

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NEWS

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…
October 9, 2026

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