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6626 News Found

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg
Drug Approval | April 10, 2024

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly


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


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


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


Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData
Drug Approval | April 06, 2024

Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData

The approval marks a significant milestone for the American pharmaceutical company in the field of UC


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


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


EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes
Drug Approval | April 03, 2024

EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes

This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia


Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO  International Non-proprietary Names
News | April 02, 2024

Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO International Non-proprietary Names

Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus