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Results For "FDA"

1717 News Found

Dr. Reddy's Laboratories launches Lenalidomide Capsules in the U.S.
News | September 09, 2022

Dr. Reddy's Laboratories launches Lenalidomide Capsules in the U.S.

Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.


Bayer showcases cancer study data at ESMO Congress 2022
News | September 01, 2022

Bayer showcases cancer study data at ESMO Congress 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors


Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US
News | August 31, 2022

Hikma launches seasonal allergic rhinitis nasal spray RYALTRIS in the US

This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US


Moderna files for emergency use of BA.4/BA.5 Omicron booster
Biotech | August 28, 2022

Moderna files for emergency use of BA.4/BA.5 Omicron booster

Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September


Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER
Drug Approval | August 27, 2022

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).


Lupin launches Desvenlafaxine extended-release tablets in the US
News | August 27, 2022

Lupin launches Desvenlafaxine extended-release tablets in the US

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.


Unichem Laboratories receives ANDA approval for Carbamazepine Tablets
Drug Approval | August 24, 2022

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets

Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA