NEWS

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Shots: Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…

12 hours ago

Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Shots: Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism Processed on IDS’ random-access automation platforms, the expanded portfolio enables…

13 hours ago

Zydus to Acquire Assertio in ~$166.4M All-Cash Deal

Shots: Assertio Holdings’ Board has approved a definitive agreement with Zydus Worldwide DMCC, a subsidiary of Zydus, to acquire all outstanding Assertio shares, delisting it from the Nasdaq Assertio’s Board determined Zydus’ proposal constituted a “Superior Proposal” under the Garda merger agreement & authorized termination of the Garda transaction As per the deal, Zydus will…

14 hours ago

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT Trial showed a…

16 hours ago

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%…

17 hours ago

Fosun Pharma Obtains Option on AriBio’s Alzheimer’s Disease (AD) Therapy AR1001

Shots: Fosun Pharma & AriBio have entered into an exclusive global option agreement for the development, registration, manufacturing, & commercialization of AR1001 for AD, expanding their partnership beyond Greater China & 10 ASEAN countries AriBio will receive a $60M option fee & retain the right to exercise the option within the agreed period, while Fosun…

18 hours ago

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Shots: The EC has approved Pfizer's Hympavzi (marstacimab; QW, SC) for the treatment of pts (≥12yrs., ≥35kg) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors, based on P-III (BASIS) study During the active treatment period, Hympavzi achieved a 93% reduction in mean treated ABR vs on-demand therapy (1.39 vs 19.78), plus…

1 day ago

Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

Shots: Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…

2 days ago

Astellas Reports the Post Hoc Analysis from GATHER Trials on Izervay in Geographic Atrophy Secondary to AMD at ARVO’26

Shots: The GATHER1 & GATHER2 studies assessed Izervay (QM) vs sham in pts with GA secondary to AMD for 18 & 12mos., respectively, where in GATHER2, pts were later re-randomized to Izervay QM or Q2M for 24mos. In the driving-eligible pts (BCVA of ≥70 ETDRS letters; n=403), Izervay reduced the risk of losing driving eligibility…

2 days ago

AstraZeneca Presents the P-III (CALYPSO) Trial Data on Eneboparatide in Chronic Hypoparathyroidism (HypoPT) at ECE’26

Shots: Trial assessed eneboparatide (ENB; QD, SC) vs PBO for 24wks. in 202 adults with HypoPT on active vitamin D & oral Ca supplements; Pts then continued ENB (ENB/ENB) or switched from PBO to ENB (PBO/ENB) in a 28wk. OLE Trial met its composite 1EP, with 31.1% pts achieving normalized albumin-adjusted sCa levels & independence…

2 days ago

NEWS

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Zydus to Acquire Assertio in ~$166.4M All-Cash Deal

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

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

Fosun Pharma Obtains Option on AriBio’s Alzheimer’s Disease (AD) Therapy AR1001

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Cepheid Receives IVDR CE Mark for Xpert GI Panel to Detect 11 Gastrointestinal Pathogens

Astellas Reports the Post Hoc Analysis from GATHER Trials on Izervay in Geographic Atrophy Secondary to AMD at ARVO’26

AstraZeneca Presents the P-III (CALYPSO) Trial Data on Eneboparatide in Chronic Hypoparathyroidism (HypoPT) at ECE’26

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