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Takeda
NEWS

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Shots: FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…
September 8, 2025

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Eli lilly
NEWS

The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50% Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ±…
September 5, 2025

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NEWS

Novatim Immune Therapeutics (Keyi Pharmaceutical) Inks a ~$1.16B Licensing Deal with RADIANCE Biopharma for KY-0301 to Treat Cancer

Shots: Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer  As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…
September 3, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022,…
September 3, 2025

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NEWS

Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Shots: Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selection Trial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…
September 1, 2025

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NEWS

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Shots: Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA…
August 28, 2025

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NEWS

Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

Shots: FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data…
August 28, 2025

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