Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

Shots:Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study…

ByRidhi Rastogi1 day ago

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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 EUThe study includes adaptive design; Part A will randomize 75-90 pts (1:1:1) to HiDAC + PBO or Annamycin (190 or 230…

ByDipanshu Dixit1 day ago

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Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots:Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

ByDipanshu DixitJune 27, 2025

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Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Shots:Pfizer reported positive topline results from the P‑III (BASIS) study evaluating HYMPAVZI (marstacimab) in hemophilia A or B pts (N=48) with inhibitors, meeting the 1EP and demonstrating a 93% reduction in annualized bleeding rate (ABR) vs. on‑demand treatment (1.39 vs. 19.78; p < 0.0001) over 12mos.HYMPAVZI, a once‑weekly SC therapy that targets TFPI,…

ByDipanshu DixitJune 27, 2025

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Royalty Pharma Purchases Revolution Medicines’ Royalty Rights of Daraxonrasib for ~2B

Shots:Royalty Pharma acquiring Revolution Medicines’ royalties for daraxonrasib (P-III RASolute 302), providing up to $1.25B across five $250M milestone tranches, plus an additional $750M debt facility in three tranchesRevolution received the $250M upfront, with future payments tied to P-III data (2026), FDA approval (by Jan 2028), and sales milestones, allowing access to further…

ByPrince GiriJune 25, 2025

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The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

Shots :Merck’s ENFLONSIA has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weightThe approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced…

ByDipanshu DixitJune 10, 2025

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CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots:CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AFThe P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…

ByRidhi RastogiMay 30, 2025

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New Drug Designations – April 2025  

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA  The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…

ByRidhi RastogiMay 27, 2025

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China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL

Shots:InnoCare Pharma has approved Minjuvi (tafasitamab) + Lenalidomide, followed by Minjuvi monotx., for treating adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT)Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, combined with lenalidomide, is already approved for treating eligible DLBCL pts. in Hong Kong, Macau,…

ByDipanshu DixitMay 21, 2025

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New Drug Designations – March 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA The March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…

ByRidhi RastogiApril 29, 2025

Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

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

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Royalty Pharma Purchases Revolution Medicines’ Royalty Rights of Daraxonrasib for ~2B

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

New Drug Designations – April 2025

China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL

New Drug Designations – March 2025

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