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 Rastogi7 hours ago

NEWS

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 Rastogi4 days ago

NEWS

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 Rastogi4 days ago

NEWS

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

NEWS

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

NEWS

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

NEWS

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

NEWS

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

NEWS

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 RastogiSeptember 25, 2026

NEWS

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

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

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

Contact US

FOLLOW US