argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

Shots: argenx has reported P-III (ADAPT OCULUS) trial data on Vyvgart (efgartigimod alfa & hyaluronidase-qvfc; SC PFS) in adults with ocular MG, where Part A randomized pts to Vyvgart (QW × 4) or PBO PH20 SC with 4wk. follow-up, & Part B provided 2 cycles of 4 QW injections separated by a 4wk. interval Trial…

ByRidhi Rastogi4 days ago

NEWS

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Shots: The US FDA has received an sBLA of Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial achieved stringent 1EP of a durable hemoglobin response & showed…

ByRidhi Rastogi5 days ago

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26) sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…

ByRidhi RastogiFebruary 3, 2026

NEWS

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Shots: The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026 sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial Ropeginterferon alfa-2b-njft received…

ByRidhi RastogiJanuary 14, 2026

NEWS

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has accepted sBLA & granted priority review to Tzield (teplizumab-mzwv) to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D (PDUFA: Apr 29, 2026) sBLA was supported by an interim 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of…

ByRidhi RastogiJanuary 5, 2026

NEWS

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

Shots: The US FDA has accepted sBLA & granted priority review to BMS' Opdivo (nivolumab) + doxorubicin, vinblastine & dacarbazine (AVD) for the treatment of pts (≥12yrs.) with previously untreated Stage III or IV cHL (PDUFA: Apr 8, 2026) sBLA was supported by the P-III (SWOG S1826/ CA2098UT) trial assessing Opdivo + AVD in above…

ByRidhi RastogiDecember 12, 2025

NEWS

Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible pts with MIBC, before the PDUFA action date (Apr 07, 2026) Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B…

ByRidhi RastogiNovember 24, 2025

NEWS

BioMarin Reports the US FDA’s sBLA Acceptance & Priority Review of Palynziq (Pegvaliase-pqpz) to Treat Phenylketonuria

Shots: The US FDA has accepted sBLA & granted priority review to Palynziq for the treatment of adolescents (12-17yrs.) with phenylketonuria (PDUFA: Feb 28, 2026) sBLA was supported by the P-III (PEGASUS) trial comparing Palynziq to diet alone in 55 adolescents with phenylketonuria, which showed reduced blood phenylalanine (Phe); results were presented at ICIEM’25 Palynziq…

ByRidhi RastogiOctober 31, 2025

NEWS

MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes

Shots: The US FDA has accepted sBLA of Afrezza (insulin human) Inhalation Powder for the treatment of children & adolescents with type 1 or type 2 diabetes (PDUFA: May 29, 2026) sBLA was supported by P-III (INHALE-1), assessing Afrezza vs multiple daily injections (MDI), both in addition to basal insulin among type1/2 diabetic pts (4-17yrs.)…

ByRidhi RastogiOctober 14, 2025

NEWS

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Shots: FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…

ByRidhi RastogiSeptember 8, 2025

argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

BMS Reports the US FDA’s sBLA Acceptance with Priority Review of Opdivo for Classical Hodgkin Lymphoma (cHL)

Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

BioMarin Reports the US FDA’s sBLA Acceptance & Priority Review of Palynziq (Pegvaliase-pqpz) to Treat Phenylketonuria

MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Contact US

FOLLOW US