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Results For "FDA"

2194 News Found

Freenome acquires global immunodiagnostics developer Oncimmune
News | May 23, 2023

Freenome acquires global immunodiagnostics developer Oncimmune

Acquisition enhances Freenome's product portfolio, including autoantibody platform with additional biomarkers important in cancer detection


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