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Tag: usfda

You Searched For "usfda"
Moderna seeks USFDA nod for updated COVID vaccine

Moderna seeks USFDA nod for updated COVID vaccine

Ruchika Sharma25 Jun 2023 11:45 AM IST
Cambridge: Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, has announced that it has completed...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

USFDA successfully concludes inspection at Granules India Jeedimetla facility

Ruchika Sharma24 Jun 2023 12:30 PM IST
Hyderabad: Granules India has recently announced that Company’s Jeedimetla facility located at Hyderabad, Telangana, India has successfully completed...
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

Hair loss drug: Pfizer Litfulo for adults, adolescents approved by USFDA

Ruchika Sharma24 Jun 2023 11:30 AM IST
LITFULO is a kinase inhibitor which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of...
Lupin wins USFDA nod for Tiotropium Dry Powder Inhaler

Lupin wins USFDA nod for Tiotropium Dry Powder Inhaler

Ruchika Sharma22 Jun 2023 11:39 AM IST
This product will be manufactured at Lupin's Pithampur facility in India.
Eli Lilly-Boehringer Ingelheim bags USFDA nod for Type 2 diabetes drugs Jardiance, Synjardy for children

Eli Lilly-Boehringer Ingelheim bags USFDA nod for Type 2 diabetes drugs Jardiance, Synjardy for children

Ruchika Sharma21 Jun 2023 4:30 PM IST
United States: The U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly and partner Boehringer Ingelheim's drugs Jardiance and...
Pfizer gets USFDA approval for Talzenna, Xtandi combo for prostate cancer treatment

Pfizer gets USFDA approval for Talzenna, Xtandi combo for prostate cancer treatment

Ruchika Sharma21 Jun 2023 12:30 PM IST
TALZENNA (talazoparib) is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair.
Acne drug: Zydus Lifesciences bags USFDA nod for Minocycline Hydrochloride ER tablets

Acne drug: Zydus Lifesciences bags USFDA nod for Minocycline Hydrochloride ER tablets

Ruchika Sharma20 Jun 2023 12:30 PM IST
The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, India.
Senores Pharma arm facility gets 3 USFDA observations

USFDA issues EIR for Lupin Vizag facility

Ruchika Sharma20 Jun 2023 11:26 AM IST
The inspection closed with the facility receiving an inspection classification of "No Action Indicated".
US FDA Guidance for Industry on Diabetes Therapies- Revisited

US FDA Guidance for Industry on Diabetes Therapies- Revisited

Isra Zaman19 Jun 2023 1:12 PM IST
Amidst the continuous development of newer oral anti-diabetic agents, today we are going to revisit a significant guidance draft that was issued by...
Lupin to Conduct BE Study for Synthetic Semaglutide Tablets in 3 Strengths

Lupin unveils Thiamine Hydrochloride Injection in US

Ruchika Sharma19 Jun 2023 11:31 AM IST
Thiamine Hydrochloride Injection is effective in the treatment of Thiamine (Vitamin B1) deficiency or beriberi, a serious condition caused by...
No Waiver for Faricimab: CDSCO Panel Asks Roche to Conduct Phase III Trial in India

Roche gets USFDA nod for Columvi to treat relapsed or refractory diffuse large B cell lymphoma

Ruchika Sharma18 Jun 2023 2:42 PM IST
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells.
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

USFDA inspection: Dr Reddy's Labs gets zero obervations for Bollaram facility, EIR for Srikakulam facility

Ruchika Sharma17 Jun 2023 12:10 PM IST
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has completed a GMP inspection at the...
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