Skip to content Skip to footer
Subscribe Now
INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
June 9, 2026

Read more

Celcuity
NEWS

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…
June 3, 2026

Read more

Astrazeneca
NEWS

AstraZeneca Highlights P-III (SERENA-6) Trial Data on Camizestrant Combination for ESR1 Mutated Advanced Breast Cancer at ASCO’26

Shots: AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…
June 3, 2026

Read more

NEWS

Genentech Receives the US FDA Priority Review for Giredestrant as an Adjuvant Treatment of ER+ Early-Stage Breast Cancer

Shots: The US FDA has accepted NDA & granted priority review to Genentech’s giredestrant as an adj. treatment for adults with ER+, HER2-, ESR1-mutated stage I, II, and III breast cancer (PDUFA: Nov 30, 2026) NDA was supported by the P-III (lidERA Breast Cancer) trial (n>4,100), where adj. giredestrant reduced iDFS by 30%, with 92.4%…
June 2, 2026

Read more

THOUGHTSPOT

Is Immune Priming the Missing Piece in Oncology? Oncolytics Biotech Thinks So

The oncology landscape is increasingly recognizing that the future of cancer treatment may depend just as much on immune engagement and combination strategies as on standalone therapeutic activity.  That shift in thinking is shaping much of the scientific attention surrounding pelareorep, the lead immunotherapeutic candidate being advanced by Oncolytics (NASDAQ: ONCY).  For years, oncology drug candidates were largely evaluated through…
May 28, 2026

Read more

Astrazeneca & Daiichi Sankyo
NEWS

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications

Shots: FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo For neoadj. setting, approval was backed by DESTINY-Breast11…
May 18, 2026

Read more

NEWS

Rigel Signs ~$445M Licensing Pact with Arvinas and Pfizer for Veppanu

Shots: Rigel has entered into an exclusive, global license agreement with Arvinas & Pfizer to develop, manufacture & commercialize FDA-approved Veppanu (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. As per the deal, Rigel will pay Arvinas & Pfizer $70M upfront, $15M in upon completion of transition activities, & ~$320M in milestones plus tiered royalties…
May 12, 2026

Read more

NEWS

Artera Secures FDA Clearance for AI-Based Breast Cancer Risk Tool

Shots: The US FDA has granted clearance to ArteraAI Breast, a digital pathology-based risk stratification tool for early-stage HR+ /HER2- breast cancer, expanding the company’s oncology AI platform beyond prostate cancer ArteraAI Breast uses multimodal AI combining digitized histopathology images & clinical data to generate an AI-derived risk score predicting distant metastasis risk, helping clinicians…
May 7, 2026

Read more

Briacell
NEWS

BriaCell Therapeutics Reports US FDA IND Clearance to Initiate P-I/II Trial of Bria-BRES+ in Breast Cancer

Shots: The US FDA has granted clearance to initiate P-I/II trial of BriaCell's Bria-BRES+ for the treatment of metastatic breast cancer At AACR, the preclinical data showed that Bria-BRES+ activated adaptive & innate immunity, incl. naïve T cells, dendritic cells, & NK cells, potentially enhancing efficacy & preventing immune escape in metastatic breast cancer…
May 6, 2026

Read more

Load more