Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Shots: The US FDA has received an NDA for ecopipam, a selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome NDA was supported by the P-III trial data showing that ecopipam significantly delayed time to relapse vs PBO in pediatric Tourette syndrome pts who responded to treatment during the open-label treatment period;…

ByRidhi RastogiJune 19, 2026

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Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

Shots: The US FDA has accepted sBLA for Genentech's Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027) sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above…

ByRidhi RastogiJune 18, 2026

NEWS

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026 Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…

ByRidhi RastogiJune 18, 2026

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Inhibrx Biosciences Reports the US FDA’s BLA Acceptance of Ozekibart to Treat Conventional Chondrosarcoma

Shots: The US FDA has accepted BLA of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, with no filing review issues identified yet (PDUFA: Apr 14, 2027) BLA was backed by the ChonDRAgon study assessing ozekibart vs PBO in pts with metastatic or unresectable conventional chondrosarcoma, which met its 1EP…

ByRidhi RastogiJune 17, 2026

NEWS

SurGenTec Wins the US FDA Clearance for ION-L to Treat Degenerative Disc Disease

Shots: The US FDA has granted clearance to SurGenTec's ION-L Lumbar Facet Fixation System for the treatment of skeletally mature pts with degenerative disc disease (DDD) from L3 to S1 who have failed conservative care Clearance is supported by a multicenter, IRB-approved clinical study in a high-risk, real-world patient population, with independent radiographic reviews confirming…

ByRidhi RastogiJune 16, 2026

NEWS

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

Shots: The Takeda's P-III (FirstLight & RadiantLight) trial assessed oveporexton (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO), while RadiantLight randomized 105 pts to two arms (2mg & PBO); regulatory filing is under review in the US (priority review), China & Japan At Wk. 12,…

ByRidhi RastogiJune 16, 2026

NEWS

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Shots: The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027) sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…

ByRidhi RastogiJune 16, 2026

NEWS

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26 sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…

ByRidhi RastogiJune 15, 2026

NEWS

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…

ByRidhi RastogiJune 15, 2026

NEWS

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…

ByRidhi RastogiJune 15, 2026

Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Inhibrx Biosciences Reports the US FDA’s BLA Acceptance of Ozekibart to Treat Conventional Chondrosarcoma

SurGenTec Wins the US FDA Clearance for ION-L to Treat Degenerative Disc Disease

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

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