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Results For "FDA"

1722 News Found

NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension
Drug Approval | January 31, 2025

NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma


Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year


Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr
News | January 27, 2025

Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr

The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations


Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer
News | January 27, 2025

Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer

BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation


Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr
News | January 23, 2025

Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr

The revenue from operations in Q3 FY25 is Rs. 8,358.6 crore, up 16% YoY


Briefs: Cipla and IOL Chemicals and Pharmaceuticals
News | January 21, 2025

Briefs: Cipla and IOL Chemicals and Pharmaceuticals

Mesalazine is used to treat inflammatory bowel disease


Glenmark Life Sciences rebranded as Alivus Life Sciences
News | January 19, 2025

Glenmark Life Sciences rebranded as Alivus Life Sciences

The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
News | January 16, 2025

Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby

Morepen Laboratories approves hiving off of medical devices business