Skip to content Skip to footer
Subscribe Now
Merck new
NEWS

Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The EC has approved Keytruda/Keytruda SC + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapies, in all 30 EEA member states Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda…
April 2, 2026

Read more

NEWS

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Shots: The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions &…
March 19, 2026

Read more

J&J
NEWS

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…
March 10, 2026

Read more

NEWS

Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid) 

Shots:  The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and  NovoRapid, respectively, across all 30 EEA states  Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.  Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz…
February 27, 2026

Read more

NEWS

ImmunityBio’s Anktiva + BCG Receives EC Conditional Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100) Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…
February 19, 2026

Read more

NEWS

Cytokinetics Reports the EC Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The EC has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with first EU launch expected in Germany by Q2’26 Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by…
February 18, 2026

Read more

NEWS

GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

Shots: EC approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively In SWIFT-1 (n=382) & SWIFT-2 (n=380), Exdensur reduced asthma exacerbations by 58% & 48% over 52wks. (1EP), with pooled data showing a 72%…
February 17, 2026

Read more

Load more