Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Shots: The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026) NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…

ByRidhi RastogiMarch 18, 2026

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Sun Pharma Reports US FDA’s sBLA Acceptance of Ilumya for Active Psoriatic Arthritis

Shots: The US FDA has accepted sBLA of Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA), with PDUFA target action date of Oct 29, 2026 sBLA was backed by P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with PsA over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure…

ByRidhi RastogiMarch 17, 2026

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AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Shots: The EC has approved perioperative Imfinzi + FLOT for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, based on P-III (MATTERHORN) trial; regulatory review is ongoing in Japan In the trial, Pts (n=948) received either Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles, then surgery followed by…

ByRidhi RastogiMarch 17, 2026

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Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…

ByRidhi RastogiMarch 16, 2026

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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 RastogiMarch 13, 2026

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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 RastogiMarch 12, 2026

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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 RastogiMarch 11, 2026

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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 RastogiMarch 11, 2026

NEWS

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 RastogiMarch 10, 2026

NEWS

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

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Sun Pharma Reports US FDA’s sBLA Acceptance of Ilumya for Active Psoriatic Arthritis

AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

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

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