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Results For "United-States"

888 News Found

Lupin receives USFDA approval for Brivaracetam Tablets
Drug Approval | December 23, 2022

Lupin receives USFDA approval for Brivaracetam Tablets


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules
Drug Approval | December 20, 2022

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million


USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
Drug Approval | December 20, 2022

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable


Aurigene reports results of AUR101 in phase II study in US patients
News | December 19, 2022

Aurigene reports results of AUR101 in phase II study in US patients

AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients


Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise
News | December 15, 2022

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise

The company will submit an action plan on the observations and will engage with US FDA for next steps.


Kerala Ayurveda receives US patent for its herbal formulation
News | December 15, 2022

Kerala Ayurveda receives US patent for its herbal formulation

The patent also covers the efficacy of the herbal composition in the management of metabolic syndrome disorders


Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Drug Approval | December 12, 2022

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland


Merck begins Tender Offer to acquire Imago BioSciences
News | December 12, 2022

Merck begins Tender Offer to acquire Imago BioSciences

As a result, Imago will become a subsidiary of Merck.


Concord Biotech gets SEBI nod for IPO
News | December 07, 2022

Concord Biotech gets SEBI nod for IPO

The IPO is a complete OFS by existing shareholder Helix Investment Holdings