The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

ByRidhi RastogiAugust 11, 2025

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The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots: The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitor Designation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

ByRidhi RastogiAugust 8, 2025

NEWS

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Shots: Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…

ByRidhi RastogiAugust 8, 2025

NEWS

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Shots: The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025 In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…

ByRidhi RastogiAugust 8, 2025

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Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Shots: Fapon Biopharma has enrolled the first patient in China for its P-I trial of FP008 for advanced solid tumors, conducted at Zhejiang Cancer Hospital. The patient completed the DLT observation with a favorable safety profile. The trial focuses on evaluating FP008's safety and tolerability FP008 demonstrated favorable safety and PK in monkey studies and…

ByDipanshu DixitAugust 7, 2025

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Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…

ByDipanshu DixitAugust 7, 2025

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Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

Shots: The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disorders The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25 IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…

ByRidhi RastogiAugust 5, 2025

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BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has accepted sBLA & granted priority review to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy (PDUFA: Dec 5, 2025) sBLA is supported by the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl.…

ByRidhi RastogiAugust 5, 2025

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The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots: The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic stroke Designation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onset Additionally, Revalesio is planning…

ByRidhi RastogiAugust 4, 2025

NEWS

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

Shots: The US FDA has granted 510(k) to both TalisMann & StimTrial for the management of chronic pain; limited US launch is planned in Q3’25, with broader rollout expected in early 2026 TalisMann integrates patented electric field conduction with a pulse generator to target deeper, larger nerves, & deliver long-term relief from chronic nerve pain,…

ByRidhi RastogiAugust 1, 2025

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

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