Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots: The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…

ByDipanshu DixitFebruary 19, 2025

NEWS

Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Shots: The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/m HNSCC harboring PD-L1 (CPS ≥ 1) in adults BTD was backed by interim data from ongoing P-I/II trial evaluating petosemtamab + Keytruda in mentioned pts that showed 67% response rate in 24 evaluable pts with further data presented…

ByRidhi RastogiFebruary 19, 2025

NEWS

The US FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for R/R Sézary Syndrome

Shots: The US FDA has granted BTD to lacutamab for the treatment of adults with r/r sézary syndrome after receiving ≥2L of therapy incl. mogamulizumab Designation was based on P-I as well as P-II (TELLOMAK) trial data, showing efficacy & favorable safety in pts who were heavily pre-treated with mogamulizumab Additionally, Lacutamab (anti-KIR3DL2…

ByRidhi RastogiFebruary 18, 2025

NEWS

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Shots: The UK’s MHRA & Swissmedic have approved Nemluvio (SC) for mod. to sev. PN & AD, where it is approved in adults for PN & in combination with TCS ± TCI in pts (≥12yrs.; ≥30kg) for AD who are candidates for systemic therapy. Awaits approval in Singapore & Australia Approval is based on P-III…

ByDipanshu DixitFebruary 18, 2025

NEWS

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

NEWS

Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults

Shots: The US FDA has approved Romvimza to treat symptomatic TGCT in adults for which surgery may lead to functional impairment or severe morbidity. Commercially available in the US by Feb 2025, whereas MAA is under EMA review Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs…

ByRidhi RastogiFebruary 17, 2025

NEWS

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD)

Shots: The US FDA has approved Penmenvy for individuals (10-25yrs) to protect against 5 serogroups of N. meningitidis (A, B, C, W, & Y) responsible for IMD. Meanwhile, the CDC's ACIP will vote on Feb 26, 2025, to recommend the use of Penmenvy in adolescents & young adults Approval was supported by 2 P-III…

ByRidhi RastogiFebruary 17, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & Biosimilars. Check out our full report below: Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn's Disease Read More: Eli Lilly Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration Read…

BySenior EditorFebruary 14, 2025

NEWS

CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Shots: EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…

ByRidhi RastogiFebruary 14, 2025

NEWS

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…

ByRidhi RastogiFebruary 13, 2025

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

The US FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for R/R Sézary Syndrome

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD)

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

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