SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted Fast Track Designation (FTD) to SOT106 for the treatment of soft tissue sarcoma SOT106 is an ADC that targets LRRC15, a clinically validated target broadly expressed across multiple prevalent sarcoma subtypes, & has received FDA Orphan Drug Designation for osteosarcoma treatment SOTIO plans to initiate a first-in-human clinical trial of SOT106…

ByRidhi Rastogi4 hours ago

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The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

Shots: The FDA has accepted NDA for NCX 470 (bimatoprost grenod) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (PDUFA: Apr 30, 2027) The NDA, submitted by US licensee Kowa, is supported by P-III (Mont Blanc & Denali) trial data showing IOP reductions of up to 10mmHg with a favorable safety…

ByRidhi Rastogi6 hours ago

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AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

Shots: The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn's disease (CD) Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded…

ByRidhi Rastogi1 day ago

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United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Shots: The US FDA has accepted the NDA for ralinepag to treat pulmonary arterial hypertension, with PDUFA target action date of Jun 24, 2027 NDA was supported by the P-III (ADVANCE OUTCOMES) trial assessing ralinepag vs PBO in 687 patients with PAH, where pts who completed the trial had the option to enroll in ongoing…

ByRidhi Rastogi3 days ago

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Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…

ByRidhi Rastogi4 days ago

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Shots: The EC has approved Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.) across all 30 EEA states Approval was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale co-1EPs Daybu, a synthetic analog…

ByRidhi Rastogi4 days ago

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Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

ByRidhi Rastogi4 days ago

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Regeneron Reports US FDA Approval of Pasatru for Fibrodysplasia Ossificans Progressiva

Shots: The US FDA has approved Pasatru (garetosmab-grts) to reduce the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), based on the P-III OPTIMA trial assessing 10 mg/kg (n=23) & 3 mg/kg (n=19) Pasatru vs PBO (n=21) At Wk. 56, Pasatru 10 mg/kg reduced the total number…

ByDipanshu DixitAugust 21, 2026

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Ultragenyx Receives FDA Accelerated Approval for GENGLYCOS Gene Therapy to Treat the Underlying Cause of GSDIa

Shots: Ultragenyx reported the US FDA accelerated approval to GENGLYCOS (pariglasgene brecaparvovec-opnr; DTX401) for adults and pediatric patients (≥8yrs., n=46) with glycogen storage disease type Ia (GSDIa) The approval was supported by the P-III (GlucoGene) study, in which GENGLYCOS (n=20) demonstrated a statistically significant reduction in cornstarch requirements at 48wks. vs PBO (n=24) (p<0.001). The…

ByPrince GiriAugust 20, 2026

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NORROY BIOSCIENCE Receives FDA Breakthrough Therapy and Fast Track Designations for 68Ga-NYM096 in Kidney Cancer Imaging

Shots: NORROY BIOSCIENCE reported that the FDA has granted Breakthrough Therapy and FTD to 68Ga-NYM096, a radiopharmaceutical imaging agent targeting CAIX for PET imaging of clear cell renal cell carcinoma (ccRCC) 68Ga-NYM096 is being developed as a non-invasive PET imaging agent to characterize indeterminate renal masses identified by CT or MRI and help differentiate ccRCC…

ByPrince GiriAugust 20, 2026

SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Regeneron Reports US FDA Approval of Pasatru for Fibrodysplasia Ossificans Progressiva

Ultragenyx Receives FDA Accelerated Approval for GENGLYCOS Gene Therapy to Treat the Underlying Cause of GSDIa

NORROY BIOSCIENCE Receives FDA Breakthrough Therapy and Fast Track Designations for 68Ga-NYM096 in Kidney Cancer Imaging

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