March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma

Shots: The US FDA has granted RMAT designation to MB-105 for the treatment of r/r CD5-positive T-cell lymphoma Designation was based on the ongoing P-II trial, which showed clinical activity with a favorable safety profile; initial data to be presented at ASH’25, with additional updates expected in 2026 March Bio will pursue clinical & commercial…

ByRidhi RastogiNovember 12, 2025

NEWS

Vera Therapeutics Reports the US FDA’s BLA Submission for Atacicept to Treat IgA Nephropathy

Shots: The US FDA has received the BLA seeking accelerated approval of atacicept for treating adults with immunoglobulin A nephropathy (IgAN), with the FDA’s decision expected in 2026 The BLA is supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in 431 adults with IgAN, assessing eGFR-based kidney…

ByRidhi RastogiNovember 10, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC Read More: Daiichi Sankyo Genentech Reports P-III (ALLEGORY) Trial…

ByRidhi RastogiNovember 7, 2025

NEWS

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Shots: The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts Trial…

ByRidhi RastogiNovember 7, 2025

NEWS

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Shots: FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos. Trial also showed an improved ORR (63.4% vs…

ByRidhi RastogiNovember 7, 2025

NEWS

argenx Receives Health Canada’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots: Health Canada has approved Vyvgart (efgartigimod alfa; QW, SC, PFS) as a monotx. for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) Approval was based on the ADHERE trial, showing 69% (221/322) of Vyvgart SC-treated pts had clinical improvement, regardless of prior treatment. The study met its 1EP with a 61% reduction in relapse risk vs…

ByRidhi RastogiNovember 6, 2025

NEWS

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

Shots: The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE The…

ByRidhi RastogiNovember 6, 2025

NEWS

Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Shots: The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025 In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…

ByRidhi RastogiNovember 6, 2025

NEWS

Meitheal Pharmaceuticals Receives the US FDA Approval for Contepo (Fosfomycin) Injection to Treat cUTI in Adults

Shots: Meitheal Pharmaceuticals received the US FDA approval for Contepo (fosfomycin) for injection to treat complicated urinary tract infections (cUTI), including acute pyelonephritis in adults caused by E. coli and K. pneumoniae The approval was supported by the P-II/III ZEUS (ZTI-01) study that assessed the safety and efficacy of the treatment on hospitalized pts and…

ByPrince GiriNovember 5, 2025

NEWS

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings planned Approval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma

Vera Therapeutics Reports the US FDA’s BLA Submission for Atacicept to Treat IgA Nephropathy

PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

argenx Receives Health Canada’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Meitheal Pharmaceuticals Receives the US FDA Approval for Contepo (Fosfomycin) Injection to Treat cUTI in Adults

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

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