Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

ByRidhi RastogiJuly 22, 2025

NEWS

Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Shots: The US FDA has approved Exzolt (fluralaner oral solution) to treat & control northern fowl mites (Ornithinyssus sylviarum) in chickens Exzolt is a parasiticide that targets the nervous system of northern fowl mites, killing those that ingest a blood meal, while remaining safe for laying hens & replacement chickens Exzolt, available in 1L &…

ByRidhi RastogiJuly 21, 2025

NEWS

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathy Designation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…

ByRidhi RastogiJuly 18, 2025

NEWS

The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…

ByRidhi RastogiJuly 18, 2025

NEWS

Quince Therapeutics Completes Patient Enrolment in P-III (NEAT) Trial of eDSP for Ataxia-Telangiectasia

Shots: Quince Therapeutics has completed enrolment in its P-III (NEAT) trial to assess eDSP (6 infusions once every 21–30 days) vs PBO in Ataxia-Telangiectasia pts (n=105), incl. 83 pts (6-9yrs.) in primary analysis population & 22 pts aged ≥10yrs. Trial will assess change from baseline to the last efficacy visit using RmICARS as the 1EP; pts…

ByRidhi RastogiJuly 17, 2025

NEWS

The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots: The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use Additionally, Shingrix prefilled…

ByRidhi RastogiJuly 17, 2025

NEWS

RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

Shots: Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…

ByRidhi RastogiJuly 17, 2025

INSIGHTS+

The US FDA New Drug Approvals in June 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025 The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…

ByDipanshu DixitJuly 15, 2025

NEWS

Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

Shots: The US FDA has granted clearance to TAVIPILOT Soft for real-time intra-operative guidance of transcatheter heart valve implantation TAVIPILOT Soft, set to launch by the end of 2025, is compatible with all cardiac imaging systems & will support all TAVI heart valves available on the market, thereby, allowing seamless integration in clinical settings TAVIPILOT…

ByRidhi RastogiJuly 15, 2025

NEWS

Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)

Shots: Takeda has reported data from 2 P-III (FirstLight & RadiantLight) trials assessing oveporexton over 12wks. in NT1 pts, where FirstLight randomized 168 pts in 3 arms (high dose, low dose & PBO), while RadiantLight randomized 105 pts in 2 arms (high dose & PBO) Both studies showed improvements across all doses at Wk. 12…

ByRidhi RastogiJuly 14, 2025

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Quince Therapeutics Completes Patient Enrolment in P-III (NEAT) Trial of eDSP for Ataxia-Telangiectasia

The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

The US FDA New Drug Approvals in June 2025

Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)

Contact US

OUR INFORMATION

FOLLOW US