BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Shots: The EC has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with r/r mantle cell lymphoma (MCL) after ≥2L of systemic therapy, incl. a BTK inhibitor, in all 30 EEA states Approval was based on the MCL cohort of the P-I (TRANSCEND NHL 001) trial assessing Breyanzi in adults with r/r B-cell non-Hodgkin…

ByRidhi RastogiNovember 25, 2025

NEWS

Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)

Shots: The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026 The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy Intas has an exclusive…

ByDipanshu DixitNovember 20, 2025

NEWS

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Shots: J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…

ByRidhi RastogiNovember 18, 2025

NEWS

Neurogene Reports Interim P-I/II Trial Results on NGN-401 to Treat Pediatric Patients with Rett Syndrome

Shots: Neurogene has reported interim data from the pediatric cohort (4-10yrs.) of the ongoing P-I/II trial assessing NGN-401 for the treatment of females with Rett syndrome As of Oct 30, 2025, all pediatric pts (n=8) had functional gains across Rett syndrome domains, achieving 35 developmental milestones in fine motor, communication & ambulation. These gains were…

ByRidhi RastogiNovember 13, 2025

NEWS

Doc.com Launches AI & Blockchain Telemedicine Platform in the US

Shots: Doc.com launches its AI & blockchain-powered telemedicine platform in the US to improve patient access, data security, & care coordination Pts can securely connect with licensed in-state healthcare providers via mobile using the platform, with up to 15min. of complimentary teleconsultation offered during launch, available in eligible jurisdictions & subject to applicable regulations, followed…

ByRidhi RastogiNovember 12, 2025

NEWS

Lyell Immunopharma Acquires Global Rights to LYL273 from Innovative Cellular Therapeutics in ~$860M Deal

Shots: Lyell has acquired global rights to LYL273 (excl. mainland China, Hong Kong, Macau & Taiwan) for the treatment of metastatic colorectal cancer & other GCC-expressing cancers from ICT As per the deal, ICT will receive $40M upfront, 1.9M Lyell shares, ~$30M in clinical, ~$115M in late-stage regulatory, & ~$675M in sales milestones, plus ~1.85M additional…

ByRidhi RastogiNovember 11, 2025

NEWS

Daiichi Sankyo Reports First Patient Dosing in P-I Trial of DS3610 for Solid Tumors

Shots: Daiichi Sankyo has dosed the first patient with DS3610 in P-I trial for the treatment of advanced, metastatic or unresectable solid tumors The P-I trial will evaluate DS-3610 in advanced or metastatic solid tumors to determine the recommended dose, assessing PK & immunogenicity endpoints plus safety endpoints incl. DLTs & AEs. Exploratory endpoints like…

ByRidhi RastogiNovember 11, 2025

NEWS

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

Shots: The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE The…

ByRidhi RastogiNovember 6, 2025

NEWS

GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases

Shots: GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012 As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…

ByRidhi RastogiOctober 28, 2025

NEWS

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Shots: The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026 Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…

ByDipanshu DixitOctober 28, 2025

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)

J&J Accelerates Cancer Innovation with $3.05B Halda Therapeutics Acquisition

Neurogene Reports Interim P-I/II Trial Results on NGN-401 to Treat Pediatric Patients with Rett Syndrome

Doc.com Launches AI & Blockchain Telemedicine Platform in the US

Lyell Immunopharma Acquires Global Rights to LYL273 from Innovative Cellular Therapeutics in ~$860M Deal

Daiichi Sankyo Reports First Patient Dosing in P-I Trial of DS3610 for Solid Tumors

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

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