AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Shots: The US FDA has accepted sBLA and granted Priority Review to Imfinzi (durvalumab) + enfortumab vedotin (EV) for the treatment of pts with MIBC who are ineligible for or have declined cisplatin-based CT (PDUFA: Q4’26). Regulatory review is ongoing in EU & Japan sBLA was based on the P-III (VOLGA) trial, which randomized 695…

ByRidhi Rastogi12 hours ago

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Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

Shots: The US FDA has approved Olumiant (baricitinib) for the treatment of pediatric pts (≥12yrs.) with severe alopecia areata (AA), expanding its use from treating adults with mod. to sev. active rheumatoid arthritis & sev. AA Approval was based on 36wk. data from the adolescent cohort (12 to <18yrs.) of P-III (BRAVE-AA-PEDS) study assessing Olumiant…

ByRidhi Rastogi16 hours ago

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Eli Lilly Reports the US FDA Approval for Onswik to Treat Type 2 Diabetes

Shots: The US FDA has approved Onswik (insulin efsitora alfa-gobe) along with diet and exercise to control high blood sugar in adults with type 2 diabetes Approval was based on the P-III (QWINT) trials, which evaluated Onswik (QW) in >3,400 adults with T2D; across each trial, Onswik met the 1EP, demonstrating non-inferior A1C reductions vs…

ByRidhi Rastogi3 days ago

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Neuraxpharm and Minoryx Report the EC Approval of Nezglyal for Cerebral Adrenoleukodystrophy (cALD)

Shots: EC has approved Nezglyal (leriglitazone) under exceptional circumstances for male cALD pts (2-12yrs.) with Gadolinium (Gd)-negative brain lesions, based on P-II/III (NEXUS) trial data & RWE data from compassionate use programs The first EU launch is expected in Germany by year-end, with additional launches anticipated following national reimbursement negotiations, while Neuraxpharm evaluates access pathways…

ByRidhi Rastogi3 days ago

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Elevar Therapeutics Secures the US FDA Approval for Lyrfigtu (Lirafugratinib) to Treat Cholangiocarcinoma

Shots: The US FDA has approved Lyrfigtu for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement; US availability is expected by Q4’26 In the P-I/II (ReFocus) trial, Lyrfigtu showed a cORR of 46%, an mDoR of 11.8mos., & 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), with a predictable and manageable safety…

ByRidhi Rastogi5 days ago

NEWS

The EC Approves AstraZeneca’s Trixeo Aerosphere for Uncontrolled Asthma

Shots: The EC has approved Trixeo Aerosphere(320/28.8/10μg) for the maintenance treatment of asthma in pts (≥12yrs.) who are not adequately controlled by a combination of a medium ICS & LABA Approval was based on the P-III (LOGOS & KALOS) trials evaluating Trixeo vs two fixed-dose dual-combination therapies of ICS & LABA: Symbicort pMDI & PT009 (in an…

ByRidhi RastogiSeptember 23, 2026

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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 RastogiSeptember 22, 2026

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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 RastogiSeptember 22, 2026

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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 RastogiSeptember 21, 2026

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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 RastogiSeptember 21, 2026

AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

Eli Lilly Reports the US FDA Approval for Onswik to Treat Type 2 Diabetes

Neuraxpharm and Minoryx Report the EC Approval of Nezglyal for Cerebral Adrenoleukodystrophy (cALD)

Elevar Therapeutics Secures the US FDA Approval for Lyrfigtu (Lirafugratinib) to Treat Cholangiocarcinoma

The EC Approves AstraZeneca’s Trixeo Aerosphere for Uncontrolled Asthma

Roche Reports EC Approval of Susvimo to Treat nAMD

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

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