Tag archive for ‘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...

Cipla associate Avenue Therapeutics fails to get FDA approval for IV tramadol
By businessnewstoday On Tuesday, June 15th, 2021
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Cipla associate Avenue Therapeutics fails to get FDA approval for IV tramadol

Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration (FDA) for IV tramadol as an alternative for reducing the use of conventional opioids in 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...

Amgen LUMAKRAS FDA approval - LUMAKRAS product shot
By businessnewstoday On Saturday, May 29th, 2021
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LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC

LUMAKRAS FDA approval : Amgen has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a type of non-small cell lung cancer (NSCLC) in adults. The More...

Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets
By businessnewstoday On Saturday, May 29th, 2021
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Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets

Cadila Healthcare (also known as Zydus Cadila) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Fluphenazine Hydrochloride Tablets 1 mg, 2.5 mg, 5 mg, and 10 mg. The More...

Alembic Pharmaceuticals gets FDA final approval for Doxepin Hydrochloride Capsules
By businessnewstoday On Saturday, April 24th, 2021
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Alembic Pharmaceuticals gets FDA final approval for Doxepin Hydrochloride Capsules

Alembic Pharmaceuticals announces USFDA Final Approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. Alembic Pharmaceuticals has secured final approval from the US Food & Drug More...

Bristol Myers Squibb, bluebird bio bag Abecma FDA approval for multiple myeloma in adults
By businessnewstoday On Sunday, March 28th, 2021
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BMS, bluebird bio bag Abecma FDA approval for multiple myeloma in adults

Abecma FDA approval : Bristol Myers Squibb (BMS) and bluebird bio have secured approval from the US Food and Drug Administration (FDA) for Abecma (idecabtagene vicleucel; ide-cel) for the treatment of relapsed or More...

J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization
By businessnewstoday On Sunday, February 28th, 2021
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J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization

Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for Ad26.COV2.S, a single-dose COVID-19 vaccine developed by its subsidiary Janssen 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...