GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & 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…

ByRidhi Rastogi2 days ago

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Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Shots: The EMA has received the Type II variation application for Tecvayli monotx. (teclistamab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Application was supported by the P-III (MajesTEC-9) trial assessing Tecvayli vs SoC of pomalidomide, bortezomib, & dexamethasone (PVd) or carfilzomib & dexamethasone (Kd) in 614…

ByRidhi Rastogi3 days ago

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ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots: The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1) ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) study ATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

ByRidhi Rastogi4 days ago

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LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Shots: The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs. Additionally, LENZ…

ByRidhi Rastogi4 days ago

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Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

ByRidhi Rastogi5 days ago

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AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

Shots: FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…

ByRidhi RastogiMarch 9, 2026

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Incyte’s Zynyz Receives the EC Approval to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The EC has approved Zynyz (retifanlimab) + Pt-based CT for the 1L treatment of adults with metastatic or inoperable locally recurrent SCAC Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts The trial showed a 37% reduction in the risk of progression or…

ByRidhi RastogiMarch 9, 2026

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BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA approved Sotyktu(6mg, PO, QD) for adults with active PsA based on 2 P-III trials against PBO, with POETYK PsA-1 involving 670 bDMARD-naïve pts while POETYK PsA-2 involved 624 pts who were bDMARD-naïve & treated with prior TNFα inhibitor POETYK PsA-1 showed that 54% pts achieved ACR20 compared to 34%, while 24% vs 14%…

ByRidhi RastogiMarch 9, 2026

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Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

Shots: The US FDA has approved Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab & hyaluronidase-fihj) for the treatment of adults with r/r MM, who have received ≥1L of prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent Approval was based on the ongoing P-III (MajesTEC-3) study evaluating Tecvayli + Darzalex vs investigator’s choice of Darzalex & dexamethasone with…

ByRidhi RastogiMarch 6, 2026

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Innovent Receives the NMPA Approval for Jaypirca to Treat R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The Chinese NMPA has approved Jaypirca (pirtobrutinib) for the treatment of adults with r/r CLL/SLL after ≥1L of systemic therapy incl. a BTK inhibitor Approval was based on the P-III (BRUIN CLL‑321) study assessing Jaypirca monotx. (200mg, PO, QD) vs investigator’s choice of IdelaR or BR in 238 previously treated pts with r/r CLL/SLL Trial…

ByRidhi RastogiMarch 3, 2026

GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

Incyte’s Zynyz Receives the EC Approval to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

Innovent Receives the NMPA Approval for Jaypirca to Treat R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

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