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NEWS

Leads Biolabs Reports NMPA NDA Acceptance for Opamtistomig in Previously Treated Advanced EP-NEC

Shots: Chinese NMPA CDE has accepted the NDA for opamtistomig (LBL-024) as monotx. for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) The NDA is supported by a registrational study led by Professor Shen Lin of Peking University Cancer Hospital, conducted across 34 sites; the study enrolled 96 pts with EP-NEC and completed enrollment in Aug 2025,…
August 21, 2026

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NEWS

IntraGel Therapeutics and UroGen Pharma Ink Strategic Collaboration &  Investment to Advance TumoCure & Expand Sustained-Release Oncology Pipeline

Shots: IntraGel Therapeutics has entered into a strategic collaboration and investment agreement with UroGen Pharma to advance TumoCure for advanced head and neck cancer and expand the potential application of its SRGel biodegradable sustained-release platform As per the deal, UroGen will invest up to $7M in IntraGel to support the P-II development of TumoCure and…
August 21, 2026

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NEWS

Rein Therapeutics’ LTI-03 Secures the US FDA Fast Track Designation for Idiopathic Pulmonary Fibrosis

Shots: The US FDA has granted FTD to LTI-03 for the treatment of idiopathic pulmonary fibrosis The P-II (RENEW) trial is a randomized, PBO-controlled study (n=~120) evaluating the safety, tolerability, and efficacy of LTI-03 for idiopathic pulmonary fibrosis across the US, UK, Australia, Poland, and Germany. Patients will receive 1 of 2 LTI-03 doses or…
August 21, 2026

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NEWS

VarmX Enrolls First Patient in P-III (EquilibriX-S) Trial of VMX‑C001 in Urgent Surgery

Shots: VarmX has enrolled the first pt in the global registrational P-III (EquilibriX-S) study assessing VMX-C001 vs usual pharmacologic care in pts receiving FXa inhibitors who require urgent surgery/procedures EquilibriX-S, a randomized, controlled trial is expected to recruit pts across >20 countries and assess whether a single IV dose of VMX-C001 rapidly restores hemostasis, with…
August 21, 2026

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NEWS

Regeneron Reports US FDA Approval of Pasatru for Fibrodysplasia Ossificans Progressiva

Shots: The US FDA has approved Pasatru (garetosmab-grts) to reduce the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), based on the P-III OPTIMA trial assessing 10 mg/kg (n=23) & 3 mg/kg (n=19) Pasatru vs PBO (n=21) At Wk. 56, Pasatru 10 mg/kg reduced the total number…
August 21, 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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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

IMPACT Therapeutics Inks Exclusive Licensing Agreement with Pharmanovia for Senaparib in EMEA, Australia and New Zealand

Shots: IMPACT Therapeutics has entered into an exclusive licensing agreement with Pharmanovia for the exclusive rights to manufacture, develop, and commercialise senaparib in EMEA, Australia, and New Zealand As per the deal, Pharmanovia will acquire exclusive rights to manufacture, develop & commercialise senaparib across EMEA, Australia & New Zealand, with IMPACT eligible for upfront, regulatory…
July 31, 2026

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