AstraZeneca Receives the CHMP Positive Opinion for Camizestrant to Treat Advanced Breast Cancer

Shots: The CHMP has recommended AZ's Camizestrant + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US & Japan Opinion was based on the P-III…

ByRidhi RastogiMay 26, 2026

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Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Shots: The EC has approved Agios’ Pyrukynd(mitapivat), marketed as Aqvesme in the US, for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies assessing Pyrukynd (100mg, BID) vs PBO in 194 on-transfusion-dependent pts and 258 transfusion-dependent pts, respectively Pyrukynd will be…

ByRidhi RastogiMay 25, 2026

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Daiichi Sankyo and AstraZeneca Report the US FDA Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The US FDA has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in mOS & 43% reduction in disease…

ByRidhi RastogiMay 25, 2026

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Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Shots: The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up Trial showed significant improvements in HDV RNA reduction & ALT…

ByRidhi RastogiMay 25, 2026

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Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…

ByRidhi RastogiMay 22, 2026

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Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer

Shots: Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…

ByRidhi RastogiMay 22, 2026

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Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (4, 9 & 12mg) with dose escalation vs PBO in adults with obesity/overweight & ≥1 weight-related comorbidity & without diabetes, meeting 1EP of 19% (4mg), 25.9% (9mg) & 28.3% (12mg) weight loss at 80wks. In 2EPs, retatrutide reduced waist circumference by 16.3cm (4mg), 21.8cm (9mg), & 24.1cm (12mg) vs 3.6cm.…

ByRidhi RastogiMay 21, 2026

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The US FDA Grants Priority Review to Bayer’s Kerendia for Chronic Kidney Disease Associated with Type 1 Diabetes

Shots: The US FDA has accepted sNDA & granted Priority Review to Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D) sNDA was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D Kerendia…

ByRidhi RastogiMay 21, 2026

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UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis

Shots: UCB has reported the (BE BOLD) trial data assessing Bimzelx(bimekizumab-bkzx) vs Skyrizi(risankizumab-rzaa) in 553 adults living with active psoriatic arthritis (PsA) Trial met its 1EP, with 49.1% pts achieving ACR50 at Wk. 16 vs 38.4%. The first ranked 2EP, MDA was numerically higher at Wk. 16 (43% vs 39.9%), but did not reach statistical…

ByRidhi RastogiMay 20, 2026

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Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management

Shots: Vincentage Pharma has reported topline P-III trial results evaluating VCT220 (120 0r 160mg, QD, PO) vs PBO for 52wks. in 840 Chinese adults with obesity or overweight with ≥1 weight-related comorbidity The trial met its 1EP, showing mean body weight reduction of -12.2% and -12.4% in the 120 & 160mg groups, respectively, vs -1.3% for…

ByRidhi RastogiMay 19, 2026

AstraZeneca Receives the CHMP Positive Opinion for Camizestrant to Treat Advanced Breast Cancer

Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Daiichi Sankyo and AstraZeneca Report the US FDA Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer

Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management

The US FDA Grants Priority Review to Bayer’s Kerendia for Chronic Kidney Disease Associated with Type 1 Diabetes

UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis

Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management

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