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646 News Found

IHL Launches Heart Health Calculator
Healthcare | October 23, 2022

IHL Launches Heart Health Calculator

Tech-driven calculator, which serves as a preventive tool that helps in heart risk assessment using several factors


USFDA visit to Alembic Pharmaceuticals Panelav facility
Drug Approval | October 19, 2022

USFDA visit to Alembic Pharmaceuticals Panelav facility

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


Piramal Pharma Solutions launches ADCelerate
News | October 13, 2022

Piramal Pharma Solutions launches ADCelerate

ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission


Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis
Clinical Trials | October 13, 2022

Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis

68% of children on a higher dose of Dupixent achieved histological disease remission at week 16


Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets
Drug Approval | October 07, 2022

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

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.


Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets
Drug Approval | October 04, 2022

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency


Sumitovant Biopharma and Sumitomo Pharma to acquire outstanding shares of Myovant Sciences
News | October 03, 2022

Sumitovant Biopharma and Sumitomo Pharma to acquire outstanding shares of Myovant Sciences

The proposed acquisition consideration represents an equity value for Myovant of $2.4 billion and an enterprise value of $2.5 billion.


Shilpa Medicare Hyderabad facility receives US FDA clearance
News | September 23, 2022

Shilpa Medicare Hyderabad facility receives US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties


Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets
Drug Approval | September 22, 2022

Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets

The ANDA was filed as 'First to File' submission on NCE-1 date.


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.