Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

Shots: The US FDA has granted ODD to CAL101 for the treatment of idiopathic pulmonary fibrosis (IPF) CAL101 (IV, QM for 7mos.) is being investigated in a P-II (AURORA) trial against PBO in 150 IPF pts, with enrolment open in the sites across US, UK, EU, Turkey, & South Korea, evaluating lung function per forced vital…

ByRidhi RastogiNovember 3, 2025

NEWS

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots: The NMPA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in Japan & the EU, with further filings planned Approval was based on P-III (FIBRONEER-IPF) assessing Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts, which met its 1EP of reduced FVC decline at…

ByRidhi RastogiOctober 24, 2025

NEWS

Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots: The US FDA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in China, Japan, & the EU, with further filings planned Approval was based on P-III (FIBRONEER-IPF) & P-II (Trial 2) trials, where FIBRONEER-IPF assessed Jascayd (18 or 9mg, PO, BID) vs PBO in…

ByRidhi RastogiOctober 9, 2025

NEWS

ArkBio Reports P-II Study Data Evaluating AK3280 to Treat Idiopathic Pulmonary Fibrosis (IPF)

Shots: ArkBio has reported positive top-line data from the P-II study conducted across 31 clinical sites in China to evaluate safety, tolerability, and clinical efficacy of AK3280 in IPF pts Pts who received AK3280 (100/200/300/400mg BID) demonstrated 209.4 mL increase in forced vital capacity (FVC) and a 6.4% adjusted improvement in %pFVC from baseline and…

ByPrince GiriMay 16, 2025

INSIGHTS+

New Drug Designations – August 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

BySenior EditorSeptember 18, 2023

Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

ArkBio Reports P-II Study Data Evaluating AK3280 to Treat Idiopathic Pulmonary Fibrosis (IPF)

New Drug Designations – August 2023

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