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1672 News Found

Shivalik Rasayan’s API facility gets 7 observations from USFDA
Drug Approval | April 10, 2024

Shivalik Rasayan’s API facility gets 7 observations from USFDA

These observations are procedural in nature and will be responded within the stipulated time


Eugia Steriles gets 3 observations from USFDA for injectable facility
Drug Approval | April 07, 2024

Eugia Steriles gets 3 observations from USFDA for injectable facility

The observations are procedural in nature and will be responded to within the stipulated time


Gland Pharma receives USFDA approval for Eribulin Mesylate Injection
Drug Approval | April 07, 2024

Gland Pharma receives USFDA approval for Eribulin Mesylate Injection

The Product is expected to be the first generic approval on the market


Cipla Patalganga facility gets 6 USFDA observations
Drug Approval | April 07, 2024

Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.


USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma
Drug Approval | April 06, 2024

USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial


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


Abbott receives FDA approval for TriClip
Drug Approval | April 04, 2024

Abbott receives FDA approval for TriClip

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery


Viatris launches RYZUMVl 0.75% in US
News | April 02, 2024

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours


AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Drug Approval | April 02, 2024

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial