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883 News Found

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules
Drug Approval | January 16, 2023

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India


Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults


Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain
News | January 10, 2023

Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)


Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets
Drug Approval | January 07, 2023

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


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


Torrent enters into co-marketing partnership with Boehringer Ingelheim India
News | December 15, 2022

Torrent enters into co-marketing partnership with Boehringer Ingelheim India

Empagliflozin is a novel sodium glucose co-transporter-2 (SGLT-2) inhibitor, which is useful for improving glycaemic control in adults with type-2 diabetes mellitus.


European Commission approves SPEVIGO for generalized pustular psoriasis flares
Drug Approval | December 13, 2022

European Commission approves SPEVIGO for generalized pustular psoriasis flares

EC grants conditional marketing authorization based on the EFFISAYIL trial


Takeda’s dengue vaccine QDENGA approved for use in EU
Drug Approval | December 09, 2022

Takeda’s dengue vaccine QDENGA approved for use in EU

The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022


ANSSI Wellness inaugurates its new spine clinic in Pune
Healthcare | December 06, 2022

ANSSI Wellness inaugurates its new spine clinic in Pune

Asia’s premier and USA-patented, ANSSI Wellness for spinal decompression was launched in Pune