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Tag: USFDA

You Searched For "usfda"
Orlynvah for urinary tract infections

FDA Approves oral pivmecillinam for Uncomplicated Urinary Tract Infections

Dr. Kamal Kant Kohli25 April 2024 7:00 PM IST
The U.S. Food and Drug Administration has approved oral pivmecillinam for the treatment of female adults with uncomplicated urinary tract infections...
USFDA concludes inspection at Zydus Lifesciences Ankleshwar facility

Natco Pharma gets USFDA EIR on pharmacovigilance requirements

Ruchika Sharma25 April 2024 5:44 PM IST
Telangana: Natco Pharma has informed in a BSE filing that the Company has received the Establishment Inspection Report (EIR) from the US Food and...
New treatment for Uncomplicated Urinary Tract Infections approved by FDA

New treatment for Uncomplicated Urinary Tract Infections approved by FDA

Roshni Dhar25 April 2024 5:16 PM IST
The U.S. Food and Drug Administration has approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract...
Health Bulletin 25/ April/ 2024

Health Bulletin 25/ April/ 2024

Roshni Dhar25 April 2024 4:58 PM IST
Here are the top health news for the day:FDA approves new treatment for Uncomplicated Urinary Tract InfectionsThe Food and Drug Administration (FDA)...
GSK Blenrep combos win approval in Japan for multiple myeloma

GSK application for expanded indication of Jemperli plus chemotherapy accepted by USFDA for priority review

Ruchika Sharma25 April 2024 12:40 PM IST
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for...
Alembic Pharma secures USFDA final nod for anticonvulsant drug Carbamazepine

Novartis radioligand therapy Lutathera gets USFDA nod for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Ruchika Sharma25 April 2024 12:14 PM IST
Basel: Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Lutathera (USAN: lutetium Lu 177 dotatate / INN:...
TAVR in patients with heart failure

FDA fast tracks investigational gene therapy for heart failure

Dr. Kamal Kant Kohli24 April 2024 7:30 PM IST
The US Food and Drug Administration (FDA) has granted Fast Track designation to invesigational gene therapy AB-1002 for treatment of congestive heart...
Unichem Labs Pithampur facility gets USFDA EIR

USFDA issues 10 observations for Zydus Lifesciences Jarod facility

Ruchika Sharma24 April 2024 4:01 PM IST
Ahmedabad: Zydus Lifesciences has informed in a BSE filing that the US Food and Drug Administration (USFDA) has concluded an inspection with...
Lupin bags tentative USFDA nod for HIV-1 infection drug

USFDA issues EIR for Lupin Aurangabad facility

Ruchika Sharma24 April 2024 11:46 AM IST
Mumbai: Global pharma major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States...
Zydus Lifesciences launches Mirabegron ER Tablets in US for overactive bladder treatment

Zydus Lifesciences launches Mirabegron ER Tablets in US for overactive bladder treatment

Ruchika Sharma22 April 2024 2:47 PM IST
Mirabegron is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
Takeda gets UK nod for rare blood disorder treatment

Takeda gets USFDA nod for Entyvio subcutaneous administration for Crohn's disease

Ruchika Sharma21 April 2024 10:00 AM IST
Osaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO (vedolizumab) subcutaneous (SC)...
Roche launches Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity

Roche Alecensa gets USFDA nod for ALK-positive early-stage lung cancer

Ruchika Sharma20 April 2024 12:05 PM IST
Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment following...
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