Latest Articles in Regulatory
Glenmark Gets USFDA Nod For First-in-human Study For Tumors, Lymphomas
Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals, the global pharmaceuticals company received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GR
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DCGI Alerts States, UTs Against Raw Materials From Maya Chemtech, Supplier Of Marion Biotech
The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi has issued a letter to the states and union territory licensing authorities against the usage of raw materials produced by Delhi based Maya Chemtech India that supplied the ingredients for the drugs at Marion Biotech which caused
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Marksans Pharma Gets USFDA Nod For Famotidine Tablets
The OTC Famotidine Tablets USP, 10 mg and 20 mg, are acid reducers which used to treat conditions where reduction of stomach acid is needed, such as acid indigestion, occasional heartburn, or sour stomach from eating or drinking certain foods or beverages
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Zydus Gets Approval For Generic Anti-viral Cream From FDA
Acyclovir belongs to a class of medications known as antivirals. Acyclovir cream is used to treat cold sores (fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. The product will be launched shortly in the US market
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Zydus Gets USFDA Nod For Vigabatrin Oral Solution
Vigabatrin for oral solution is indicated for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older
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Alembic Pharma Announces USFDA Approval For Docetaxel Injection
Docetaxcel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck
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USFDA Clears Sanofi's Bleeding Disease Therapy
Sanofi's replacement therapy - Altuviiio - is entering a market dominated by rivals like Takeda Pharmaceutical, Bayer AG and Novo Nordisk, which sell factor replacement therapies that have been the standard treatment for decades
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Zydus Lifesciences Receives Nod From USFDA For Pitavastatin Tablets
Pitavastatin is an HMG-CoA reductase inhibitor indicated as adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol
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GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems Over Mechanical Issues
GE Nuclear Medicine 600 and 800 Series systems are used by healthcare professionals to evaluate diseases, trauma, abnormalities, and disorders. These systems create images of the body to help healthcare providers assess organ function or detect and diagnose issues such as cardiovascular disease, neu
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Lupin Receives Approval From USFDA For Glycopyrrolate Injection
Glycopyrrolate injection is used before and during surgeries to lessen mouth, throat, or stomach secretion, or to prevent heart rhythm problems or unwanted effects caused by certain medicines
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