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INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
June 9, 2026

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VIEWPOINTS

Jared Kelly on Immune Priming & Survival Outcomes: Oncolytics Biotech’s Vision for Pelareorep

Shots:  Oncolytics Biotech is advancing pelareorep beyond the traditional standalone therapy model, positioning the platform as a potential immune-priming backbone capable of enhancing immunotherapies, checkpoint inhibitors, chemotherapies, and other oncology treatments across multiple difficult-to-treat tumor settings.  The company continues generating growing survival and immune-engagement data across colorectal, pancreatic, and anal cancers, while emphasizing pelareorep’s potential to “turn cold tumors…
June 3, 2026

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NEWS

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

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NEWS

Delcath Systems Publishes Subgroup Analyses of The P-III Study on Unresectable Metastatic Uveal Melanoma Patients

Shost: Delcath Systems has reported the publication of subgroup analyses from the Phase 3 (FOCUS) study in the Journal of Cancer Research and Clinical Oncology, evaluating the efficacy and safety of the HEPZATO KIT on melphalan/hepatic delivery in pts with unresectable metastatic uveal melanoma In the subgroup analyses (n=91) of the P-III (FOCUS) Study pts,…
January 2, 2026

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Evorpacept’s Momentum in HER2+ Gastric Cancer: A Conversation with Jason Lettmann from ALX Oncology 

Shots:  Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells  Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…
December 3, 2025

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Breaking New Ground in Oncology: Leonard Mazur from Citius Pharmaceuticals in Conversation with PharmaShots 

Shots:   Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma     In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape    Leonard also highlights Mino-Lok, Citius’ innovative…
October 6, 2025

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