Skip to content Skip to footer
Subscribe Now
INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

Read more

Amgen
NEWS

The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   

Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…
March 26, 2026

Read more

NEWS

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

Read more

VIEWPOINTS

Evorpacept’s Momentum in HER2+ Gastric Cancer: A Conversation with Jason Lettmann from ALX Oncology 

Shots:  Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells  Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…
December 3, 2025

Read more

ThoughtSpot_Saurabh Chaubey9
THOUGHTSPOT

Targeted Therapy in Oncology

Shots:  The oncology domain accounts for more than 50% of ongoing clinical trials. The global oncology drug market was valued at $185B in 2022 and is predicted to reach $205B by 2030 with a 13% CAGR   Targeted therapy targets specific genes and proteins to prevent them from growing and spreading. In 2022, the market size…
January 3, 2024

Read more