Boehringer Ingelheim and CDR-Life Expand their Partnership with a Global Licensing Deal for CDR111

Shots: Boehringer Ingelheim and CDR-Life signed a global licensing deal to develop CDR111, a trispecific M-gager T-cell engager targeting and depleting B cells to help reset the immune system in autoimmune diseases As per the deal, CDR-Life could receive up to CHF 456M (~$570M), including CHF 38M (~$ 48M) upfront and near-term payments, plus tiered…

ByDipanshu DixitNovember 5, 2025

NEWS

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings planned Approval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

NEWS

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

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Shots: The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment options Approval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…

ByRidhi RastogiOctober 28, 2025

NEWS

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin Alfa for Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Shots: Sanofi has reported the P-II (ElevAATe) trial data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (QW) in 97 adults with AATD emphysema for ~32wks. Trial met its 1EP with a greater mean increase in functional AAT (fAAT) levels at Wk. 32 & achieved key 2EPs of higher fAAT levels &…

ByRidhi RastogiOctober 24, 2025

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Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos. Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…

ByDipanshu DixitOctober 21, 2025

NEWS

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Shots: The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…

ByRidhi RastogiOctober 21, 2025

NEWS

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancer MAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & showed favorable safety Relacorilant (PO) is a GR antagonist that is…

ByRidhi RastogiOctober 15, 2025

NEWS

SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)

Shots: SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs First patient dosing triggered $250M milestone payment to SystImmune under its 2023 deal with BMS, where SystImmune is further eligible to receive additional ~$250M in contingent near-term payments & ~$7.1B…

ByRidhi RastogiOctober 14, 2025

NEWS

BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

Shots: The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapy Decision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…

ByRidhi RastogiOctober 13, 2025

Boehringer Ingelheim and CDR-Life Expand their Partnership with a Global Licensing Deal for CDR111

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

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

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin Alfa for Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)

BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

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