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Results For "United-States"

1202 News Found

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules
Drug Approval | June 12, 2024

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace


Briefs: Dr. Reddy's Laboratories and Ami Organics
News | June 08, 2024

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility


Merck completes € 180 million investment to expand Schnelldorf Distribution Center
Supply Chain | June 07, 2024

Merck completes € 180 million investment to expand Schnelldorf Distribution Center

Merck has opened its newly expanded Life Science distribution center in Schnelldorf, Germany


Bionova Scientific aims to set up new Plasmid DNA GMP facility neat Houston, US
News | June 03, 2024

Bionova Scientific aims to set up new Plasmid DNA GMP facility neat Houston, US

Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA-based, and recombinant protein therapeutics in Q1/2025


FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma
Drug Approval | May 30, 2024

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients


Merck to acquire EyeBio for US$ 1.3 billion upfront payment
News | May 30, 2024

Merck to acquire EyeBio for US$ 1.3 billion upfront payment

Acquisition includes Restoret, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration


Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL
Drug Approval | May 29, 2024

Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL

Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation


Asahi Kasei to acquire Calliditas Therapeutics AB to accelerate growth
News | May 29, 2024

Asahi Kasei to acquire Calliditas Therapeutics AB to accelerate growth

Asahi Kasei will offer to acquire all of the ordinary shares of Calliditas


Alvotech and Dr. Reddy’s collaborate for commercialization of AVT03 (denosumab)
News | May 27, 2024

Alvotech and Dr. Reddy’s collaborate for commercialization of AVT03 (denosumab)

Dr. Reddy’s gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK)


Zydus receives final approval from USFDA for Theophylline ER Tablets
Drug Approval | May 25, 2024

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease