BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

Shots: The EMA has granted PRIority MEdicines (PRIME) designation to BGB-16673 for the treatment of pts with Waldenstrom’s macroglobulinemia (WM), who previously were treated with a BTK inhibitor Designation was based on data showing BGB-16673’s novel ability to degrade both wild-type & mutant BTK forms, incl. resistance-linked variants, which demonstrated anti-tumor activity in B-cell malignancies…

ByRidhi Rastogi4 days ago

INSIGHTS+

New Drug Designations: June 2025

Shots:    PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA The June 2025 edition covers designations awarded to 43 drugs and 3 medical devices, comprising 17 small molecules, 7 biologics, 8 cell and gene therapies, and…

ByRidhi RastogiJuly 29, 2025

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Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Shots: The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM) Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390) At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive…

ByRidhi RastogiJuly 24, 2025

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EMA Marketing Authorization of New Drugs in June 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 6 new chemical entities in June 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was SpringWorks Therapeutics’ Ogsiveo to Treat Desmoid Tumours PharmaShots has compiled a list of 8 drugs that have been…

ByDipanshu DixitJuly 22, 2025

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The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots: The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use Additionally, Shingrix prefilled…

ByRidhi RastogiJuly 17, 2025

NEWS

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Shots: Moleculin received approval from Georgia’s RAMPA to initiate its global P-IIb/III (MIRACLE) study of AnnAraC (Annamycin + cytarabine) in R/R AML, and first pt dosing expected by Aug-end; CTA already approved in EU The study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…

ByDipanshu DixitJuly 11, 2025

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Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

Shots: The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…

ByRidhi RastogiJuly 9, 2025

NEWS

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Shots: The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA states Approval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some…

ByRidhi RastogiJuly 8, 2025

NEWS

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

S Shots: Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…

ByPrince GiriJune 30, 2025

NEWS

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Shots: Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and Iceland BRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…

ByDipanshu DixitJune 27, 2025

BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

New Drug Designations: June 2025

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

EMA Marketing Authorization of New Drugs in June 2025

The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Moleculin Receives RAMPA’s CTA Approval for P-IIb/III (MIRACLE) Study of AnnAraC in R/R AML

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

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