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Tag: usfda

You Searched For "usfda"
Zydus Lifesciences gets USFDA EIR for formulation manufacturing facility at SEZ 2, Ahmedabad

Zydus Lifesciences gets USFDA EIR for formulation manufacturing facility at SEZ 2, Ahmedabad

Ruchika Sharma20 Sept 2023 11:19 AM IST
Ahmedabad: Zydus Lifesciences has announced that the company has received the Establishment Investigation Report (EIR) report from...
Lupin receives USFDA observations for two Pithampur manufacturing Units

USFDA issues 1 observation for Aurobindo Pharma arm AP facility

Ruchika Sharma20 Sept 2023 10:00 AM IST
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued a ‘Form 483’ with 1 observation at...
FDA issues urgent warning against Natures Ozempic or India seeds for weight loss

FDA issues urgent warning against Nature's Ozempic or "India seeds for weight loss"

Isra Zaman20 Sept 2023 9:45 AM IST
In a joint announcement, the Food and Drug Administration (FDA) and the Maryland Department of Health have issued a stark warning about certain weight...
Medical Bulletin 19/September/2023

Medical Bulletin 19/September/2023

Isra Zaman19 Sept 2023 3:15 PM IST
Here are the top medical news of the day:Researchers uncover surprising side effects of common diabetes drug MetforminMetformin, a well-established...
FDA approves JAK inhibitor Momelotinib for Myelofibrosis in Anemic adults

FDA approves JAK inhibitor Momelotinib for Myelofibrosis in Anemic adults

Isra Zaman19 Sept 2023 9:30 AM IST
The US Food and Drug Administration (FDA) has approved momelotinib for the treatment of intermediate or high-risk myelofibrosis, including primary...
Medical Bulletin 18/September/2023

Medical Bulletin 18/September/2023

Isra Zaman18 Sept 2023 3:15 PM IST
Here are the top medical news of the day:FDA approves new and updated indications for temozolomideThe Food and Drug Administration (FDA) recently...
FDA approves new and updated indications for temozolomide

FDA approves new and updated indications for temozolomide

Isra Zaman18 Sept 2023 10:00 AM IST
The Food and Drug Administration (FDA) recently approved updated labeling for temozolomide under an initiative aimed at updating labeling information...
Akums Drugs & Pharma opens new facility

CDSCO panel rejects Akum Pharma's proposal to study Roxadustat Tablets

Susmita Roy17 Sept 2023 6:00 PM IST
New Delhi: Raising safety concerns with the drug Roxadustat, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Strides Pharma Science Acetaminophen and Ibuprofen Tablets

Strides Pharma Science Singapore gets tentative USFDA approval for Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate tablets

Ruchika Sharma16 Sept 2023 12:30 PM IST
Bangalore: Strides Pharma Science Limited has announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore,...
Expanded age indication for GSK’s AREXVY

GSK gets USFDA nod for bone marrow cancer therapy Ojjaara

Ruchika Sharma16 Sept 2023 11:54 AM IST
Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.
Zydus Lifesciences bags USFDA nod for Norelgestromin, Ethinyl Estradiol Transdermal System to prevent pregnancy

Zydus Lifesciences bags USFDA nod for Norelgestromin, Ethinyl Estradiol Transdermal System to prevent pregnancy

Ruchika Sharma15 Sept 2023 3:40 PM IST
The transdermal patch will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad.
GSK, Pfizer resolve patent lawsuit over RSV vaccines

JnJ, P&G, Walgreens accused in lawsuits over cold medicine decongestant

Ruchika Sharma15 Sept 2023 2:30 PM IST
Johnson & Johnson, Procter & Gamble and Walgreens are among several companies accused in lawsuits of deceiving consumers about cold...
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