BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Shots: The US FDA has accepted NDA & granted Priority Review to infigratinib (PO) for the treatment of children with achondroplasia (PDUFA: Feb 4, 2027). BridgeBio is prepared to launch infigratinib upon approval Trial met its 1EP, with infigratinib improving annualized height velocity at Wk. 52 (mean treatment difference: +2.10cm/yr.) & its key 2EP of…

ByRidhi Rastogi42 minutes ago

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Abbott Receives FDA Approval for New CardioMEMS HF System Patient-Facing Capabilities

Shots: Abbott received US FDA approval for updates to the CardioMEMS HF System, enabling patients in the US to view their pulmonary artery pressure (PAP) readings through the CardioGuide HF App The updated system includes Dynamic Treatment Plan (DTP), allowing care teams to create personalized medication adjustment plans based on changes in PAP and send…

ByPrince Giri1 day ago

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The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

Shots: The US FDA has approved an additional indication for Jaypirca (pirtobrutinib, 100 & 50mg) for the treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion Approval was based on the P-III (BRUIN CLL-313) trial data P-III assessing Jaypirca (200mg, PO, QD until disease progression…

ByRidhi Rastogi2 days ago

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BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Camzyos (mavacamten) for the treatment of symptomatic oHCM to improve functional capacity & symptoms in adults & pediatric pts (≥30kg) Approval was based on P-III (SCOUT-HCM) trial data assessing Camzyos (n=23) vs PBO (n=21) in 44 pts (12 to <18yrs.) with symptomatic NYHA class II-III oHCM, which met its 1EP,…

ByRidhi RastogiOctober 1, 2026

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Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Shots: The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…

ByRidhi RastogiOctober 1, 2026

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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 RastogiSeptember 29, 2026

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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 RastogiSeptember 29, 2026

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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 RastogiSeptember 28, 2026

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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 RastogiSeptember 28, 2026

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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 RastogiSeptember 25, 2026

BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Abbott Receives FDA Approval for New CardioMEMS HF System Patient-Facing Capabilities

The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

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

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