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Latest Industry News - Page 128

AstraZeneca-Daiichi Sankyo Enhertu gets USFDA Breakthrough Therapy Designation in HER2-positive early breast cancer

Expert Panel Approves Post-Marketing Surveillance Study of Eculizumab (Soliris) by AstraZeneca in India

Dr. Divya Colin6 July 2025 3:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to...
Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Emcure Pharma incorporates new wholly-owned subsidiary Emcure Wellness

Ruchika Sharma6 July 2025 1:30 PM IST
Pune: Emcure Pharmaceuticals Limited has announced the incorporation of a new wholly-owned subsidiary named Emcure Wellness Private Limited. The...
JnJ wins USFDA approval for subcutaneous Rybrevant Faspro for EGFR-Mutated NSCLC

JnJ seeks indication extension of Akeega from EMA for adults with metastatic hormone-sensitive prostate cancer, HRR gene alterations

Ruchika Sharma6 July 2025 12:30 PM IST
Belgium: Janssen-Cilag International NV, a Johnson & Johnson company, has announced the submission of an extension of indication application...
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA Breakthrough Therapy Designation in HER2-positive early breast cancer

AstraZeneca Imfinzi approved in EU for muscle-invasive bladder cancer

Ruchika Sharma6 July 2025 11:00 AM IST
Cambridge: AstraZeneca has received approval for Imfinzi (durvalumab) in the European Union (EU) for the treatment of adult patients...
Pfizers Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

Pfizer's Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

Parthika Patel6 July 2025 10:00 AM IST
New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO)...
COVID-19 Vaccine and Heart Attack: Biocon Chief, Karnataka CM get into war of words

COVID-19 Vaccine and Heart Attack: Biocon Chief, Karnataka CM get into war of words

Ruchika Sharma5 July 2025 5:03 PM IST
Bengaluru: A war of words has erupted between Biocon founder Kiran Mazumdar-Shaw and Karnataka Chief Minister Siddaramaiah on thursday over...
CDSCO Panel Accepts Glenmarks Apremilast Trial Report, Seeks 2-Year PSUR Data

CDSCO Panel Asks Glenmark To Justify BE Waiver for FDC Inhalation Suspension With Scientific Evidence

Dr. Divya Colin5 July 2025 3:36 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has advised Glenmark...
CDSCO Panel Denies Trial Waiver for Atropine, Asks Sun Pharma to Conduct Phase III Study

Sun Pharma Gets SEC Nod to Begin Phase III Trial of Cough Drug Gefapixant

Dr. Divya Colin5 July 2025 3:21 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended granting...
Merck in Talks to Acquire Revolution Medicines in USD 28-32 Billion Oncology Deal

USFDA grants priority review for Winrevair label update based on ZENITH Trial: Merck

Ruchika Sharma5 July 2025 2:39 PM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has...
AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

AstraZeneca, Summit in discussions over USD 15 billion cancer drug licensing deal: Report

Ruchika Sharma5 July 2025 12:47 PM IST
Bengaluru: AstraZeneca is reportedly in discussions with Summit Therapeutics to license an experimental lung cancer drug in a deal that could be...
Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Bain Capital divests 2.4 percent stake in Emcure Pharma for Rs 563 crore

Ruchika Sharma5 July 2025 11:57 AM IST
New Delhi: US-based Private investment firm Bain Capital has pared down its stake in Emcure Pharmaceuticals, offloading a 2.4 percent...
CDSCO Panel Asks Shilpa Biologicals to Revise Phase III Protocol for Recombinant Human Serum Albumin Study

Shilpa Pharma Lifesciences Unit-1 successfully completes GMP inspection from Brazilian regulatory authority

Ruchika Sharma4 July 2025 5:16 PM IST
Karnataka: Shilpa Medicare Limited's 100 percent subsidiary, Shilpa Pharma Lifesciences Limited, Unit-1 has successfully completed GMP inspection...
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Latest Triple Combination of Empagliflozin, Sitagliptin, and Metformin for Advanced Care in Indian T2DM Patients- When to Consider?

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