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NEWS

NORROY BIOSCIENCE Receives FDA Breakthrough Therapy and Fast Track Designations for 68Ga-NYM096 in Kidney Cancer Imaging

Shots: NORROY BIOSCIENCE reported that the FDA has granted Breakthrough Therapy and FTD to 68Ga-NYM096, a radiopharmaceutical imaging agent targeting CAIX for PET imaging of clear cell renal cell carcinoma (ccRCC) 68Ga-NYM096 is being developed as a non-invasive PET imaging agent to characterize indeterminate renal masses identified by CT or MRI and help differentiate ccRCC…
August 20, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026    

Shots:  The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.  EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
August 18, 2026

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Innocare Pharma
NEWS

InnoCare Pharma Reports NMPA Approval for P-III Trial of Mesutoclax + Azacitidine in Treatment-Naive AML

Shots: Chinese NMPA has approved the P-III trial of mesutoclax (ICP-248) in combination with azacitidine vs venetoclax with azacitidine in elderly or unfit pts with treatment-naïve acute myeloid leukemia (TN AML) At ASCO’26, the combination achieved an 81.8% composite CR rate in evaluable TN AML pts (as of Apr 13, 2026), with 86.5% of responders…
August 18, 2026

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EXCLUSIVE

Oncolytics Biotech’s Next Chapter: Jared Kelly on Advancing Pelareorep Toward Approval  

Shots  Pelareorep is gaining regulatory momentum through multiple FDA interactions and Fast Track designations, providing greater clarity around potential registration pathways and shaping Oncolytics’ clinical development and partnership strategy.  REO-033 could mark a pivotal step toward registration as the randomized study in RAS-mutant MSS metastatic colorectal cancer builds on encouraging clinical data and has the potential to become…
August 17, 2026

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INSIGHTS+

The US FDA New Drug Approvals in July 2026 

Shots:  The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.   Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…
August 11, 2026

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INSIGHTS+

Key Biosimilars Events of July 2026 

Shots:  July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.   Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…
August 4, 2026

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NEWS

Curium and Lantheus to Merge in an ~$8B Deal

Shots: Lantheus to merge with a wholly-owned subsidiary of Curium US, combining Curium’s global theranostics platform with Lantheus’ US radiodiagnostics business; closing expected in H1’27 As per the deal, Curium will acquire Lantheus for $102.5/share in cash, with shareholders eligible for ~$12/share in non-transferable CVRs, representing total consideration of up to $114.50/share & a transaction…
August 4, 2026

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NEWS

Pathos AI Inks ~2.2B Licensing Deal with Alphamab Oncology for JSKN016

Shots: Pathos AI has entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals for JSKN016, a TROP2/HER3 bispecific ADC independently developed by Alphamab As per the deal, Pathos AI will receive exclusive rights to research, develop, manufacture & commercialize JSKN016 outside Greater China, funding all related costs, while Alphamab retains exclusive rights in mainland China,…
August 4, 2026

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NEWS

Corbus Pharmaceuticals Reports FDA Clearance to Initiate TEMPO-1 Trial of CRB-701 in OPSCC

Shots: The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026 Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to…
July 29, 2026

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NEWS

CORE Biomedicine Licenses Preclinical Oncology Portfolio from Eisai

Shots: CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…
July 29, 2026

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