BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…

ByRidhi RastogiMay 14, 2026

NEWS

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Shots: ALX Oncology presented data from exploratory analyses of P-Ib/II trial assessing evorpacept + Ziihera in pts with heavily pre-treated HER2+ mBC, all of whom had received prior Enhertu therapy, at ESMO Breast Cancer 2026 Exploratory analyses in 24 pts treated with evorpacept + Ziihera at dosages of 20mg/kg (n=3) or 30mg/kg (n=21), showed a…

ByRidhi RastogiMay 8, 2026

NEWS

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Shots: Beacon has reported the 12mos. data from P-II (DAWN) trial assessing laruparetigene zovaparvovec (laru-zova) in pts with XLRP who have previously been treated with an AAV vector-based gene therapy delivering the full-length RPGR protein Data showed sustained improvements in low luminance visual acuity (LLVA) & microperimetry mean sensitivity through Mos. 12, with 50% of…

ByRidhi RastogiMay 8, 2026

NEWS

BriaCell Therapeutics Reports US FDA IND Clearance to Initiate P-I/II Trial of Bria-BRES+ in Breast Cancer

Shots: The US FDA has granted clearance to initiate P-I/II trial of BriaCell's Bria-BRES+ for the treatment of metastatic breast cancer At AACR, the preclinical data showed that Bria-BRES+ activated adaptive & innate immunity, incl. naïve T cells, dendritic cells, & NK cells, potentially enhancing efficacy & preventing immune escape in metastatic breast cancer…

ByRidhi RastogiMay 6, 2026

NEWS

Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Shots: Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…

ByRidhi RastogiMay 5, 2026

NEWS

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots: The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…

ByRidhi RastogiApril 29, 2026

NEWS

J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has accepted sBLA & granted priority review to J&J's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial showed that pts treated with Imaavy…

ByRidhi RastogiApril 28, 2026

NEWS

Cumberland Pharmaceuticals Sells Branded Portfolio to Apotex in $100M Deal

Shots: Cumberland has entered into an agreement to sell its portfolio of branded US products to an affiliate of Apotex for $100M in cash, which will create a platform to deliver specialty medicines The move separates Cumberland’s commercial business from its R&D operations, allowing the company to focus on advancing its pipeline product candidates post-closing,…

ByRidhi RastogiApril 24, 2026

NEWS

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Shots: Otarmeni was approved under CNPV for pediatric & adult pts with sev. to profound and profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function & no prior cochlear implant. It will be provided free of charge in the US by Regeneron Approval was based on the P-I/II…

ByRidhi RastogiApril 24, 2026

NEWS

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Shots: The US FDA has accepted IND application of DMX-1001 (oral noribogaine) for the treatment of alcohol use disorder (AUD) DemeRx completed a MAD trial of DMX-1001 in healthy volunteers, demonstrating safety, tolerability, & PK supportive of P-II in AUD. The company plans to initiate a P-II trial of DMX-1001 in AUD in 2027 Noribogaine…

ByRidhi RastogiApril 23, 2026

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

BriaCell Therapeutics Reports US FDA IND Clearance to Initiate P-I/II Trial of Bria-BRES+ in Breast Cancer

Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

J&J Receives the US FDA Priority Review for Imaavy to Treat Warm Autoimmune Hemolytic Anemia (wAIHA)

Cumberland Pharmaceuticals Sells Branded Portfolio to Apotex in $100M Deal

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Contact US

FOLLOW US