J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

Shots: The US FDA has received sNDA of Caplyta (lumateperone) for the prevention of relapse in schizophrenia; sNDA of Caplyta as an adjunctive therapy for MDD is under FDA’s review sNDA was supported by withdrawal P-III (Study 304) trial assessing Caplyta (42mg, QD) for 18wk. open-label phase followed by a double-blind phase, where pts received…

ByRidhi RastogiJuly 9, 2025

NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…

ByRidhi RastogiJune 20, 2025

NEWS

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots: The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025) The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…

ByDipanshu DixitJune 11, 2025

NEWS

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoing Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP),…

ByRidhi RastogiJune 4, 2025

NEWS

Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

Shots: The US FDA has accepted sNDA & granted priority review to Empaveli for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (PDUFA: Jul 28, 2025) Submission was backed by P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label…

ByRidhi RastogiApril 2, 2025

NEWS

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10…

ByRidhi RastogiJanuary 22, 2025

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

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