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Results For "FDA"

1783 News Found

Granules India received ANDA approval for Venlafaxine ER capsules
Drug Approval | May 20, 2023

Granules India received ANDA approval for Venlafaxine ER capsules

Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder


Farxiga’s expanded approval highlights potential to differentiate in HF space, says GlobalData
News | May 17, 2023

Farxiga’s expanded approval highlights potential to differentiate in HF space, says GlobalData

Farxiga is expected to have such a strong influence on the market due to the impressive results


Medico Remedies to foray into ointment manufacturing segment
News | May 15, 2023

Medico Remedies to foray into ointment manufacturing segment

The facility will have a capacity to manufacture upto 3 million tubes monthly


Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute
News | May 15, 2023

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations


Cigniti bags ‘Best IoT Healthcare Platform’ award in 2023
News | May 10, 2023

Cigniti bags ‘Best IoT Healthcare Platform’ award in 2023

The Awards recognizes standout digital health & medical technology products and companies


Briefs: Dr. Reddy's Laboratories
News | May 06, 2023

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation


Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays
News | May 04, 2023

Strides and Orbicular enter into a strategic partnership to develop a range of nasal sprays

The partnership will commercialize four nasal sprays with a combined Global IQVIA market size in excess of $400m


Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma