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Results For "USFDA"

1133 News Found

Dr. Reddy's launches Toripalimab in India
News | December 01, 2024

Dr. Reddy's launches Toripalimab in India

The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma


FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Biotech | November 26, 2024

FDA approves BridgeBio’s Attruby for ATTR-CM treatment

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR


Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals
News | November 20, 2024

Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals

Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities


Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%
News | November 16, 2024

Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%

EBITDA for the quarter is Rs. 21.6 crore as against Rs. 18.1 crore in Q2 FY24


Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr
News | November 07, 2024

Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr

US Generics grew 5% to Rs. 467 Crores for the quarter


Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Drug Approval | October 19, 2024

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA


FDA approves VYALEV for adults living with advanced parkinson's disease
Drug Approval | October 18, 2024

FDA approves VYALEV for adults living with advanced parkinson's disease

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease


Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting