Innovent Reports NMPA Approval for Jaypirca (Pirtobrutinib) to Treat CLL/ SLL

Shots: The NMPA has approved Jaypirca (100 & 50mg) as a monotx. for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), expanding its use across all lines of therapy & regardless of prior covalent BTK inhibitor treatment Approval was backed by the P-III trials: BRUIN CLL-313 assessed Jaypirca in 282 pts with treatment-naïve…

ByRidhi Rastogi5 hours ago

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AbbVie Reports the US FDA Approval of Juvmo (Tavapadon) for Parkinson’s Disease

Shots: FDA approval was based on the P-III (TEMPO) program, which evaluated Juvmo in early PD pts not taking oral levodopa (TEMPO-1 & 2) & as an adjunct to oral levodopa vs PBO + levodopa in PD pts with motor fluctuations (TEMPO-3) At Wk. 26 in TEMPO-1, Juvmo showed MDS-UPDRS Part II scores of −1.6…

ByRidhi Rastogi7 hours ago

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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 Rastogi1 day 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 Rastogi1 day 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 Rastogi4 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 Rastogi4 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 RastogiSeptember 24, 2026

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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

Innovent Reports NMPA Approval for Jaypirca (Pirtobrutinib) to Treat CLL/ SLL

AbbVie Reports the US FDA Approval of Juvmo (Tavapadon) for Parkinson’s Disease

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)

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