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Pfizer New
NEWS

The US FDA Approves Pfizer’s Tukysa as 1L Maintenance Treatment for HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Tukysa + trastuzumab & pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2+ breast cancer following induction treatment Approval was supported by the P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy…
3 days ago

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Eli lilly
NEWS

Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

Shots: FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET) Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the…
September 21, 2026

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NEWS

Biocon Secures 10-Year Pertuzumab Supply Agreement in Brazil  

Shots:  Biocon has entered into a partnership agreement with Bahiafarma & Bionovis for pertuzumab biosimilar in Brazil to advance production & commercialisation of the HER2+ breast cancer therapy under the country’s PDP program  The Biocon, Bahiafarma & Bionovis consortium received 100% allocation under 10-year PDP program for pertuzumab, providing exclusive access to the public healthcare…
September 8, 2026

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Astrazeneca
NEWS

AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

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) +…
September 7, 2026

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NEWS

Vara Gains CE Certification for Autonomous Breast Cancer Screening AI

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…
September 2, 2026

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Celcuity
NEWS

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 ±…
August 27, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026    

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…
August 18, 2026

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