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Results For "approval"

2477 News Found

Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Drug Approval | April 06, 2024

Enhertu approved in the US as first tumour-agnostic HER2-directed therapy

Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers


Aster DM Healthcare concludes separation of India and GCC businesses
Healthcare | April 05, 2024

Aster DM Healthcare concludes separation of India and GCC businesses

The company plans to add 1700 beds by FY27 through the organic route


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer
Drug Approval | March 30, 2024

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations


EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer
Drug Approval | March 28, 2024

EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer

Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant


Caplin Group commences operations of Rs. 150 crore oncology facility
News | March 28, 2024

Caplin Group commences operations of Rs. 150 crore oncology facility

The facility will manufacture tablets, capsules, and injections for the oncology segment


Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
Drug Approval | March 27, 2024

Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder

First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+


FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension
Drug Approval | March 27, 2024

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension

WINREVAIR is a breakthrough biologic for this rare, progressive disease


USFDA grants ODD to Cevidoplenib for immune thrombocytopenia
News | March 23, 2024

USFDA grants ODD to Cevidoplenib for immune thrombocytopenia

Oscotec has successfully completed phase 2 study in patients with chronic ITP last year