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Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer
News | June 22, 2024

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population


Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC
Drug Approval | June 22, 2024

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types


Roche receives FDA clearance on its digital pathology solution for diagnostic use
News | June 20, 2024

Roche receives FDA clearance on its digital pathology solution for diagnostic use

This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions


USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit
Drug Approval | June 19, 2024

USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations


FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans
Medical Device | June 19, 2024

FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans

Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government


Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules
Drug Approval | June 19, 2024

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients


Indian medical device industry to touch US$ 50 billion by 2030
Healthcare | June 17, 2024

Indian medical device industry to touch US$ 50 billion by 2030

India's healthcare sector anticipates telemedicine reaching US$ 5.4 billion by 2025, with AI growing at 45% by 2024 and Healthtech jobs increasing 15-20%


Alembic announces USFDA final approval for Icatibant injection
Drug Approval | June 17, 2024

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals


Imfinzi approved in the US for endometrial cancer
Drug Approval | June 17, 2024

Imfinzi approved in the US for endometrial cancer

Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy


Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27%
Clinical Trials | June 17, 2024

Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27%

First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting