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Maroc Maroc - DRUGS.COM - New Drug Approvals - 19/Jul 19:07

FDA Approves Zituvimet XR (sitagliptin and metformin hydrochloride) Extended-Release Tablets for Adults with Type 2 Diabetes

Ahmedabad, India, 19 July 2024 Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval for its New Drug Application (NDA) from the United States Food and Drug...

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Indies Pharma looking to double sales after securing FDA drug approval

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Drug company Indies Pharma Jamaica Limited is looking to double next year’s revenues, following approval of its abbreviated new drug application,...

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Indoco Remedies receives US FDA final approval to market generic Lucemyra tablets

pharmabiz.com - 11/Sep 12:11

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for lofexidine...

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Indoco Remedies receives US FDA final approval to market generic Lucemyra tablets

pharmabiz.com - 11/Sep 12:11

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for lofexidine...

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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

drugs.com - 03/Sep 20:09

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....

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Zydus Lifesciences Limited’s Acquisition of a Stake in Sterling Biotech

globallegalchronicle.com - 10/Sep 00:00

Khaitan & Co. advised Zydus Lifesciences Limited (Zydus) on the deal. Zydus Lifesciences Limited (Zydus) secured the acquisition of 50% equity...

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Zydus Lifesciences Limited’s Acquisition of a Stake in Sterling Biotech

globallegalchronicle.com - 10/Sep 00:00

Khaitan & Co. advised Zydus Lifesciences Limited (Zydus) on the deal. Zydus Lifesciences Limited (Zydus) secured the acquisition of 50% equity...

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KalVista announces FDA acceptance of NDA for sebetralstat for oral on-demand treatment of HAE

haei.org - 03/Sep 17:29

KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...

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Roche Gets FDA Approval for Subcutaneous Formulation of Tecentriq

zacks.com - 13/Sep 16:54

The FDA approves subcutaneous formulation of RHHBY's leading immunotherapy drug, Tecentriq, under the brand name Tecentriq Hybreza.