Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Shots: The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026 Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO…

ByRidhi Rastogi5 days ago

NEWS

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…

ByRidhi RastogiJune 25, 2026

NEWS

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Shots: The US FDA has accepted sBLA & granted priority review to adj. Tecentriq (atezolizumab) & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) in combination with CT in stage III dMMR or MSI-H colon cancer (PDUFA: Oct 9, 2026) sBLA was based on the P-III (ATOMIC) trial assessing Tecentriq to FOLFOX6 CT in 712 pts with stage…

ByRidhi RastogiJune 11, 2026

NEWS

Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC

Shots: The EC has approved Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after 1L treatment with Pt-based CT Approval was based on the P-III (DeLLphi-304) trial assessing Imdelltra vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the…

ByRidhi RastogiJune 2, 2026

NEWS

Revolution Medicines Highlights P-III (RASolute 302) Trial Results on Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer

Shots: As of Feb 10, 2026 (mFU: 8.5mos.), the P-III trial assessing daraxonrasib (300mg, QD, PO; n=248) vs CT (n=252) in previously treated metastatic PDAC, regardless of RAS mutation, met all 1 & key 2EPs, showing benefits in both the RAS G12 mutant (daraxonrasib n=228; CT n=231) & overall population Daraxonrasib improved OS by 60% in…

ByRidhi RastogiJune 1, 2026

NEWS

Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026

Shots: Lilly's global P-III (LIBRETTO-432) trial assessed Retevmo (selpercatinib; 160mg, BID) vs PBO in 151 pts with early-stage (IB-IIIA) RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy Trial met the 1EP, improving the EFS by 83% in stage II–IIIA RET-positive NSCLC (n=109), with 24mos. EFS rates of…

ByRidhi RastogiJune 1, 2026

NEWS

Eli Lilly Reports the P-Ib (Heart-2) Trial Data on VERVE-102 as a One-Time Treatment for Hypercholesterolemia

Shots: Trial assessed Lilly's VERVE-102 (IV; 0.3, 0.45, 0.6, 0.7, 0.8 & 1mg/kg) in 35 adults with HeFH or premature coronary artery disease who required additional LDL-C lowering despite maximally tolerated oral lipid-lowering therapy Single infusion of VERVE-102 led to dose-dependent PCSK9 reductions of 51% (0.3mg/kg) to 88% (1mg/kg), with corresponding mean LDL-C reductions of…

ByRidhi RastogiMay 26, 2026

NEWS

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

NEWS

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension Trial met…

ByRidhi RastogiMay 18, 2026

NEWS

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26 Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…

ByRidhi RastogiApril 24, 2026

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC

Revolution Medicines Highlights P-III (RASolute 302) Trial Results on Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer

Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026

Eli Lilly Reports the P-Ib (Heart-2) Trial Data on VERVE-102 as a One-Time Treatment for Hypercholesterolemia

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

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Contact US

FOLLOW US