Tag archive for ‘US FDA’
Alkem Laboratories gets Form 483 from US FDA for St. Louis manufacturing facility
By businessnewstoday On Saturday, June 19th, 2021
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Alkem Laboratories gets Form 483 from US FDA for St. Louis plant

(adsbygoogle = window.adsbygoogle || []).push({}); Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations. Form 483 More...

US FDA issues warning letter to Lupin Limited over its manufacturing facility in Somerset, New Jersey
By businessnewstoday On Monday, June 14th, 2021
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Lupin Limited gets FDA warning letter for Lupin Somerset site

Indian pharma company Lupin Limited said that it has been issued a warning letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Somerset, New Jersey. The warning letter follows More...

Lupin Limited gets FDA approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
By businessnewstoday On Monday, June 7th, 2021
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Lupin Limited gets FDA nod for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

Lupin Limited (Lupin) said it has secured approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the US Food and Drug Administration (FDA). Emtricitabine and Tenofovir Disoproxil More...

Glenmark Pharmaceuticals gets FDA approval for Theophylline Extended-Release Tablets generic
By businessnewstoday On Friday, June 4th, 2021
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Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg. The Indian pharma company’s Theophylline Extended-Release More...

Sparta Biomedical’s SBM-01 Biomimetic Implant gets FDA breakthrough device status
By businessnewstoday On Saturday, April 24th, 2021
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Sparta’s SBM-01 Biomimetic Implant gets FDA breakthrough device status

Sparta Biomedical said that its SBM-01 Biomimetic Implant has secured a breakthrough device designation from the US Food and Drug Administration for the replacement of damaged knee cartilage, as per an announcement More...

Ambrx’s ARX788 gets FDA orphan drug status for gastric cancer treatment
By businessnewstoday On Saturday, April 24th, 2021
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Ambrx’s ARX788 gets FDA orphan drug status for gastric cancer treatment

Ambrx has announced that its antibody drug conjugate (ADC) ARX788 has been granted orphan drug designation by the US Food and Drug Administration for the treatment of patients having HER2-positive gastric cancer. The More...

Caplin Steriles, a subsidiary of Caplin Point Laboratories, gets FDA approval for Prochlorperazine Edisylate Injection
By businessnewstoday On Saturday, April 24th, 2021
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Caplin Point Laboratories gets FDA approval for Prochlorperazine Edisylate Injection

Caplin Point Laboratories said that its subsidiary Caplin Steriles has secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Prochlorperazine Edisylate More...

Transcenta gets US FDA clearance for launching phase 1 trial of TST005
By businessnewstoday On Tuesday, April 20th, 2021
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Transcenta gets US FDA clearance for launching phase 1 trial of TST005

Transcenta has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug Administration (FDA) for launching a phase I clinical trial of the bi-functional anti-PD-L1/TGF-β More...

MSCP wraps up $330m sale of majority stake in Hojeij Branded Foods to Lagardere
By pharmanewsdaily On Sunday, February 28th, 2021
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FDA authorizes emergency use of Janssen COVID-19 Vaccine

The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine – Ad26.COV2.S manufactured by Johnson & Johnson subsidiary Janssen Biotech. It More...

By pharmanewsdaily On Tuesday, January 26th, 2021
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US FDA approves Opdivo, Cabometyx combo for advanced renal cell carcinoma

The US Food and Drug Administration (FDA) has approved the combination of Bristol Myers Squibb’ Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib) as a first line therapy for advanced renal cell carcinoma More...