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1569 News Found

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


Glenmark launches Triple FDC of Teneligliptin with Pioglitazone and Metformin for adults with Type 2 Diabetes
News | December 22, 2022

Glenmark launches Triple FDC of Teneligliptin with Pioglitazone and Metformin for adults with Type 2 Diabetes

This FDC has been launched under the brand name Zita-PioMet, and contains Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) in a sustained release (SR) formulation


Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer
Diagnostic Center | December 22, 2022

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe


Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules
Drug Approval | December 20, 2022

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million


USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
Drug Approval | December 20, 2022

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

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


Ezharima launched in Japan as first dual EZH1 and EZH2 inhibitor therapy for leukemiaLymphoma
News | December 20, 2022

Ezharima launched in Japan as first dual EZH1 and EZH2 inhibitor therapy for leukemiaLymphoma

EZHARMIA is the fifth innovative oncology medicine to be launched in Japan by Daiichi Sankyo in the past three years


Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers
Drug Approval | December 20, 2022

Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers

Positive opinions based on significant survival benefit


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


Emmes appoints Ching Tian as Chief Innovation Officer
People | December 16, 2022

Emmes appoints Ching Tian as Chief Innovation Officer

Her previous role at Novartis, where she was general manager, data & digital, in global drug development, also included accountability for driving the DCT strategy, programs and platforms


Takeda launches CINRYZE in India for hereditary angioedema patients
News | December 15, 2022

Takeda launches CINRYZE in India for hereditary angioedema patients

CINRYZE is plasma-derived C1-I NH approved for routine prevention (prophylaxis), short-term prevention or pre-procedure prevention, and acute attacks of HAE.