Roche Reports EC Approval of Susvimo to Treat nAMD

Shots: The EC has approved Susvimo (ranibizumab 100mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal) Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to ranibizumab (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi Rastogi10 hours ago

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Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Shots: J&J has reported the P-III (Study 451) trial data, assessing Caplyta (lumateperone; 42mg, QD) vs PBO for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder, at Psych Congress 2026 Trial met its 1EP, showing a 4.8-point greater reduction in YMRS total score at Wk. 3, with…

ByRidhi Rastogi11 hours ago

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Johnson & Johnson Reports the EC Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The EC has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA 0/1 & 55%…

ByRidhi Rastogi14 hours ago

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Corcept Therapeutics Reports the CHMP Positive Opinion of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Shots: The CHMP has recommended Lifyorli (relacorilant) + nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer; EC decision is expected in Q4’26 Approval was backed by the P-II trial and P-III (ROSELLA) study assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) across the US, EU, South Korea, Brazil, Argentina, Canada…

ByRidhi Rastogi1 day ago

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AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis

Shots: The CHMP has recommended Klygefa(gefurulimab; SC, QW) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are AChR antibody-positive; filings are under review in the US, China & other countries Opinion was supported by the P-III (PREVAIL) trial assessing Klygefavs PBO in 260 gMG adults for…

ByRidhi Rastogi1 day ago

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Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

Shots: FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET) Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the…

ByRidhi Rastogi2 days ago

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IntraBio Reports the US FDA Approval of Aqneursa for Ataxia-Telangiectasia

Shots: The US FDA has approved Aqneursa (levacetylleucine) for the treatment of ataxia in adult & pediatric pts (≥15kg) with ataxia-telangiectasia (A-T) Approval was backed by the P-III (IB1001-303) trial assessing Aqneursa vs PBO in 73 pts (4-50yrs.) with genetically confirmed A-T, which met its 1 & key 2EPs & showed that Aqneursa has a…

ByRidhi Rastogi2 days ago

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Zealand Pharma Reports CHMP Positive Opinion for Zeydovio (Glepaglutide) for Short Bowel Syndrome (SBS)

Shots: The CHMP has recommended Zeydovio (glepaglutide) for the treatment of adults with SBS. Zealand is pursuing partnerships for the future global commercialization of Zeydovio for SBS Opinion was based on the P-III (EASE-1) trial of Zeydovio (10mg, QW or Q2W) vs PBO in 106 SBS pts with intestinal failure (IF), dependent on parenteral support…

BySaurabh Chaubey4 days ago

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Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

Shots: The CHMP has recommended Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for pts with resectable muscle-invasive bladder cancer (MIBC); if approved, authorization would be valid in all 30 EEA states Opinion was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj.…

ByRidhi Rastogi4 days ago

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Bayer’s Kerendia Secures US FDA Approval for Chronic Kidney Disease Associated with T1D

Shots: The US FDA has approved Kerendia (finerenone, 10 & 20mg) for the treatment of adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D) Approval was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D Kerendia +…

ByRidhi RastogiSeptember 17, 2026

Roche Reports EC Approval of Susvimo to Treat nAMD

Johnson & Johnson Reports the P-III (Study 451) Trial Data on Caplyta in Bipolar Mania

Johnson & Johnson Reports the EC Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Corcept Therapeutics Reports the CHMP Positive Opinion of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis

Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

IntraBio Reports the US FDA Approval of Aqneursa for Ataxia-Telangiectasia

Zealand Pharma Reports CHMP Positive Opinion for Zeydovio (Glepaglutide) for Short Bowel Syndrome (SBS)

Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

Bayer’s Kerendia Secures US FDA Approval for Chronic Kidney Disease Associated with T1D

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