Us Fda
-
{
- All
- News
- Videos
-
Eli Lilly Gets US FDA Nod For Once-Weekly Onswik Insulin For Type 2 Diabetes
Lilly’s FDA approval is based on the QWINT Phase 3 programme, which evaluated Onswik in more than 3,400 adults with type 2 diabetes across four clinical trials.
-
Aurobindo Pharma Gets First USFDA Nod For First Metered-Dose Inhaler
The USFDA approval for Aurobindo Pharma's first metered-dose inhaler takes its cumulative ANDA approvals to 596, strengthening its complex product portfolio.
-
Trump Picks Dr. Heidi Overton, A Top White House Aide, To Lead The Food And Drug Administration
Overton is a medical doctor and deputy director of the White House Domestic Policy Council who has worked on several of Trump's second-term health initiatives
-
Piramal Pharma Share Price Gains Over 3% As US FDA Closes Inspection
Stock prices of Piramal Pharma jumps as the company announced completion of US FDA GMP inspection of the Sellersville facility
-
India's First Homegrown Antibiotic Zaynich Gets US FDA Approval; Here's What You Need To Know About The Drug
Zaynich is a novel injectable antibiotic developed to treat serious bacterial infections, especially complicated urinary tract infections. It is a combination of two components; cefepime, a fourth-generation cephalosporin antibiotic, and zidebactam, a new molecule developed by Wockhardt.
-
Lupin's Pune Facility Gets Four Observations After US FDA Inspection
The US FDA conducted a product-specific pre-approval inspection at the company’s Pune biotech facility from Sept. 8 to Sept. 19, according to an exchange filing.
-
US Food Authority Issues Warning Against This Indian Cookware Brand. Here's Why
The cookware is a Kadai/Karahi by Tiger White, manufactured by Saraswati Strips Pvt. Ltd. in India under the name Pure Aluminium Utensils (Tiger White).
-
No Need For Reading Glasses? Vizz Eye Drop That Improves Near Vision Has FDA Nod
The US FDA approval of Vizz was based on results from three randomised, double-masked, controlled Phase 3 studies.
-
Aurobindo Pharma's US Plant Gets 11 FDA Observations
The inspection took place from March 24 to April 10, 2025.
-
Gland Pharma's Hyderabad Facility Receives Establishment Inspection Report From USFDA
In August 2024, the US FDA concluded the inspection with three observations.
-
Aarti Drugs Shares Close 12% Higher After USFDA Issues 'VAI' Tag For Tarapur Facility
Due to the clearance from USFDA, Aarti Drugs can now export a number of products to the US market.
-
"Tea Is Healthy": India's Favourite Beverage Gets US FDA's Approval
The FDA announced a final rule updating the "healthy" nutrient content claim to help consumers identify foods that align with dietary recommendations.
-
Alembic Pharmaceuticals Receives US FDA Nod For Diltiazem Hydrochloride Capsules To Treat Hypertension
Alembic Pharmaceuticals’ newly approved Diltiazem Hydrochloride capsules, with an estimated $105.3 million market size, offer therapeutic equivalence to Bausch Health's Cardizem CD capsules.
-
Cipla Share Price Snaps Two-Day Fall To Post Best Session Since July 2023—Here's Why
Cipla's strong recovery came after the US Food and Drug Administration concluded inspection at its Goa facility with 'Voluntary Action Indicated', which paved the way for Abraxane generic launch.
-
Granules India Gets US FDA Nod For Tablets To Treat Major Depressive Disorder
The tablet that received the approval is therapeutically equivalent to Wellbutrin SR sustained-release tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC, an exchange filing said.
-
Eli Lilly Gets US FDA Nod For Once-Weekly Onswik Insulin For Type 2 Diabetes
Lilly’s FDA approval is based on the QWINT Phase 3 programme, which evaluated Onswik in more than 3,400 adults with type 2 diabetes across four clinical trials.
-
Aurobindo Pharma Gets First USFDA Nod For First Metered-Dose Inhaler
The USFDA approval for Aurobindo Pharma's first metered-dose inhaler takes its cumulative ANDA approvals to 596, strengthening its complex product portfolio.
-
Trump Picks Dr. Heidi Overton, A Top White House Aide, To Lead The Food And Drug Administration
Overton is a medical doctor and deputy director of the White House Domestic Policy Council who has worked on several of Trump's second-term health initiatives
-
Piramal Pharma Share Price Gains Over 3% As US FDA Closes Inspection
Stock prices of Piramal Pharma jumps as the company announced completion of US FDA GMP inspection of the Sellersville facility
-
India's First Homegrown Antibiotic Zaynich Gets US FDA Approval; Here's What You Need To Know About The Drug
Zaynich is a novel injectable antibiotic developed to treat serious bacterial infections, especially complicated urinary tract infections. It is a combination of two components; cefepime, a fourth-generation cephalosporin antibiotic, and zidebactam, a new molecule developed by Wockhardt.
-
Lupin's Pune Facility Gets Four Observations After US FDA Inspection
The US FDA conducted a product-specific pre-approval inspection at the company’s Pune biotech facility from Sept. 8 to Sept. 19, according to an exchange filing.
-
US Food Authority Issues Warning Against This Indian Cookware Brand. Here's Why
The cookware is a Kadai/Karahi by Tiger White, manufactured by Saraswati Strips Pvt. Ltd. in India under the name Pure Aluminium Utensils (Tiger White).
-
No Need For Reading Glasses? Vizz Eye Drop That Improves Near Vision Has FDA Nod
The US FDA approval of Vizz was based on results from three randomised, double-masked, controlled Phase 3 studies.
-
Aurobindo Pharma's US Plant Gets 11 FDA Observations
The inspection took place from March 24 to April 10, 2025.
-
Gland Pharma's Hyderabad Facility Receives Establishment Inspection Report From USFDA
In August 2024, the US FDA concluded the inspection with three observations.
-
Aarti Drugs Shares Close 12% Higher After USFDA Issues 'VAI' Tag For Tarapur Facility
Due to the clearance from USFDA, Aarti Drugs can now export a number of products to the US market.
-
"Tea Is Healthy": India's Favourite Beverage Gets US FDA's Approval
The FDA announced a final rule updating the "healthy" nutrient content claim to help consumers identify foods that align with dietary recommendations.
-
Alembic Pharmaceuticals Receives US FDA Nod For Diltiazem Hydrochloride Capsules To Treat Hypertension
Alembic Pharmaceuticals’ newly approved Diltiazem Hydrochloride capsules, with an estimated $105.3 million market size, offer therapeutic equivalence to Bausch Health's Cardizem CD capsules.
-
Cipla Share Price Snaps Two-Day Fall To Post Best Session Since July 2023—Here's Why
Cipla's strong recovery came after the US Food and Drug Administration concluded inspection at its Goa facility with 'Voluntary Action Indicated', which paved the way for Abraxane generic launch.
-
Granules India Gets US FDA Nod For Tablets To Treat Major Depressive Disorder
The tablet that received the approval is therapeutically equivalent to Wellbutrin SR sustained-release tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC, an exchange filing said.
