Eli Lilly Reports P-III (TRANSCEND-T2D-1) Trial Data on Retatrutide for Type 2 Diabetes (T2D)

Shots: Trial assessed retatrutide vs PBO, alongside lifestyle intervention in T2D adults (n=537) inadequately controlled with diet & exercise alone & mean disease duration of 2.5yrs.; pts started at 2mg QW, with dose escalation at Q4W till assigned doses of 4mg, 9mg, or 12mg are reached Trial met its 1EP, showing superior A1C reduction at…

ByRidhi Rastogi4 days ago

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GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus Trial met its 1EP & key 2EPs showing…

ByRidhi Rastogi4 days ago

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Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Shots: The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions &…

ByRidhi Rastogi5 days ago

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Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Pfizer has reported P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi in 599 pts with HRR gene-mutated mHSPC Trial met its 1EP, showing improved rPFS with a hazard ratio surpassing the pre-specified target of 0.63, as most pts remained progression-free; consistent benefit was observed across tumors with both…

ByRidhi Rastogi5 days ago

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AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

Shots: AL-S Pharma has reported the global P-II (AP-101-02) trial data assessing AP-101 (IV, Q3W) vs PBO in 73 pts with sporadic ALS (n=52) & SOD1 mutations (n=21) for 24wks., followed by 24wk. OLE phase, where all pts received AP-101, & 16wk. safety follow-up Trial met its 1EP for safety & tolerability, with AP-101 showing…

ByRidhi Rastogi5 days ago

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JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the…

ByRidhi Rastogi5 days ago

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FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Asian Longhorned and Gulf Coast Tick

Shots: The US FDA has approved label expansion of Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension) for dogs to treat & control Asian longhorned tick (H. longicornis) & Gulf Coast tick (A. maculatum) for 12mos. The extended-release injectable Bravecto Quantum provides a once-yearly dosing option for improved compliance & continuous protection, & is available exclusively…

ByRidhi Rastogi5 days ago

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Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy or phototherapy 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…

ByRidhi Rastogi5 days ago

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Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Shots: The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3) Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS Venglustat received US…

ByRidhi RastogiMarch 18, 2026

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Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula

Shots: The US FDA has approved MyChoice CDx Test as a companion diagnostic for for HRD+ identification in pts with advanced ovarian cancer who may benefit from treatment with Zejula (niraparib) Approval was based on the PRIMA trial assessing Zejula vs PBO in ovarian cancer pts with complete or partial response to 1L Pt-based CT,…

ByRidhi RastogiMarch 18, 2026

Ridhi Rastogi

Eli Lilly Reports P-III (TRANSCEND-T2D-1) Trial Data on Retatrutide for Type 2 Diabetes (T2D)

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Asian Longhorned and Gulf Coast Tick

Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula

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