Shots:
The US FDA has granted IND clearance to initiate P-I trial of PRT13722 in HR+/HER2− breast cancer, with patient enrollment expected to begin in Q4’26
The P-I study will assess PRT13722’s safety, tolerability, PK, PD & antitumor activity as monotx. & in combination with endocrine or targeted therapies in adults with locally advanced/metastatic HR+/HER2−…
Shots:
FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations
Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) +…
Shots:
Vara has secured CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening, enabling normal examinations to be reported without radiologist review
ATMON (Autonomous-Triage Monitoring) is a real-time system that monitors AI performance, mammography hardware, system health, & site-level signals. If predefined limits are exceeded, the…
Shots:
The EC has approved Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with unresectable or metastatic HER2+ (IHC 3+ or ISH+) breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)
Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior…
Celcuity Reports the US FDA sNDA Submission for Revtorpyk for HR+/HER2-, PIK3CA Mutant Breast Cancer
Shots:
The US FDA has received sNDA for Revtorpyk (gedatolisib) for the treatment of pts with HR+, HER2-, locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on or after treatment with ≥1L of endocrine therapy
sNDA was supported by the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of Revtorpyk + fulvestrant ±…
Shots:
The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.
EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
Shots:
Rigel has reported the availability of Veppanu (vepdegestrant) by prescription in the US for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following ≥1L of endocrine therapy
Veppanu (200mg, PO, QD) is an FDA-approved PROTAC, a class of targeted protein degraders that uses the body’s natural machinery to…
Shots:
The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.
Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…
Shots:
The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)
Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
Shots:
The EC has approved Etcamah + 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
Approval was based on the P-III (SERENA-6) trial assessing…

