AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

Shots: The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…

ByRidhi RastogiApril 28, 2026

NEWS

Boehringer Ingelheim Reports P-III (SYNCHRONIZE-1) Trial Data on Survodutide for Weight Loss

Shots: BI has reported P-III (SYNCHRONIZE-1) trial assessing survodutide (BI 456906; 3.6 or 6mg, QW) vs PBO in 725 adults living with obesity or overweight, without type 2 diabetes Trial met co-1EP, with ~85.1% achieving ≥5% weight loss vs 38.8%, & 16.6% sustained mean loss vs 3.2% after 76wks. (efficacy estimand), mainly driven by fat…

ByRidhi RastogiApril 28, 2026

NEWS

Pixee Medical’s Knee+ NexSight Receives the US FDA 510(k) Clearance for Knee Arthroplasty

Shots: The US FDA has granted 510(k) clearance to Knee+ NexSight, its AR-based total knee arthroplasty solution Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need of robot, console, or disposables, while delivering robotic-level accuracy with less invasive tools, reduced blood loss, & seamless workflow integration Knee+ NexSight supports…

ByRidhi RastogiApril 28, 2026

NEWS

Thermo Fisher Scientific to Divest Microbiology Unit to Astorg for ~$1.08B

Shots: Thermo Fisher Scientific has agreed to sell its microbiology business to Astorg for ~$1.075B, incl. cash & a $50M seller note, as part of its portfolio optimization strategy The divested unit, which offers antimicrobial susceptibility testing and culture media solutions, generated $645M in revenue in 2025 and operates within Thermo Fisher’s Specialty Diagnostics segment…

ByRidhi RastogiApril 28, 2026

NEWS

J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has accepted sBLA & granted priority review to J&J's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial showed that pts treated with Imaavy…

ByRidhi RastogiApril 28, 2026

NEWS

Eli Lilly to Acquire Ajax Therapeutics for ~$2.3B

Shots: Eli Lilly has entered into a definitive agreement to acquire Ajax Therapeutics, incl. its lead asset AJ1-11095, strengthening Lilly's capabilities in blood cancers As per the deal, Lilly will acquire Ajax for ~$2.3B in cash, inclusive of an upfront payment & subsequent clinical & regulatory milestone payments AJ1-11095 (PO, QD), a Type II JAK2…

ByRidhi RastogiApril 27, 2026

NEWS

Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

Shots: The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments…

ByRidhi RastogiApril 27, 2026

NEWS

AstraZeneca Reports FDA Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…

ByRidhi RastogiApril 27, 2026

NEWS

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…

ByRidhi RastogiApril 27, 2026

NEWS

Novartis’ Itvisma Receives the CHMP Positive Opinion for Spinal Muscular Atrophy

Shots: The CHMP has recommended Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Opinion was based on the P-III (STEER) trial & P-IIIb (STRENGTH) study, where STEER showed a 2.39-point improvement in the HFMSE with effects sustained…

ByRidhi RastogiApril 27, 2026

Ridhi Rastogi

AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

Boehringer Ingelheim Reports P-III (SYNCHRONIZE-1) Trial Data on Survodutide for Weight Loss

Pixee Medical’s Knee+ NexSight Receives the US FDA 510(k) Clearance for Knee Arthroplasty

Thermo Fisher Scientific to Divest Microbiology Unit to Astorg for ~$1.08B

J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)

Eli Lilly to Acquire Ajax Therapeutics for ~$2.3B

Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

AstraZeneca Reports FDA Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Novartis’ Itvisma Receives the CHMP Positive Opinion for Spinal Muscular Atrophy

Contact US

FOLLOW US