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2095 News Found

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Quizartinib granted priority review in the U.S.
Drug Approval | October 26, 2022

Quizartinib granted priority review in the U.S.

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone


Novartis maintains growth momentum; Confirms FY’22 Group guidance
News | October 26, 2022

Novartis maintains growth momentum; Confirms FY’22 Group guidance

Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.


Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Govt celebrates 7th Ayurveda Day 2022
Policy | October 23, 2022

Govt celebrates 7th Ayurveda Day 2022

A MoU was signed between Ministry of Ayush and Ministry of Tribal Affairs to collaborate in Ayush sector


Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation
Diagnostic Center | October 23, 2022

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint


Aarti Drugs Q2 FY23 revenue up 19%; Profit down 5.6%
News | October 21, 2022

Aarti Drugs Q2 FY23 revenue up 19%; Profit down 5.6%

Around 62% of the revenues came from the domestic market and 38% from the exports market for Q2 FY23 for a standalone business


USFDA visit to Alembic Pharmaceuticals Panelav facility
Drug Approval | October 19, 2022

USFDA visit to Alembic Pharmaceuticals Panelav facility

None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable