The US FDA New Drug Approvals in July 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025 The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Regeneron’s Lynozyfic, securing…

ByDipanshu DixitAugust 12, 2025

NEWS

GSK’s Blenrep (Belantamab Mafodotin) Regimens Receive the EC’s Approval to Treat R/R Multiple Myeloma

Shots: The EC has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy. Review ongoing in the US (PDUFA: Oct 23, 2025) & China (priority review for DREAMM-7) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade…

ByRidhi RastogiJuly 25, 2025

NEWS

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…

ByDipanshu DixitJuly 24, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 2 New Chemical Entites in May 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were GSk’s Blenrep to Treat R/R Multiple Myeloma PharmaShots has compiled a list of 4 drugs that have been…

ByDipanshu DixitJune 17, 2025

NEWS

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots: J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…

ByRidhi RastogiJune 16, 2025

NEWS

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

S Shots: CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 26, 2025

NEWS

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 19, 2025

NEWS

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…

ByRidhi RastogiApril 21, 2025

NEWS

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…

ByRidhi RastogiApril 8, 2025

TOP 20

Top 20 Cell and Gene Therapy Companies of 2024

Shots: Cell and gene therapies provide a promising opportunity to enhance care for unmet healthcare needs. Biopharma companies are actively exploring these therapies across multiple indications to address healthcare gaps in rare and chronic diseases In 2023, the cell and gene therapy market was valued at $18.2B and is projected to grow to $117.46B by…

ByPrince GiriNovember 28, 2024

The US FDA New Drug Approvals in July 2025

GSK’s Blenrep (Belantamab Mafodotin) Regimens Receive the EC’s Approval to Treat R/R Multiple Myeloma

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

EMA Marketing Authorization of New Drugs in May 2025

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Top 20 Cell and Gene Therapy Companies of 2024

Contact US

OUR INFORMATION

FOLLOW US