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1544 News Found

Strides receives USFDA approval for Amantadine Hydrochloride capsules
Drug Approval | February 21, 2022

Strides receives USFDA approval for Amantadine Hydrochloride capsules

To be marketed by Strides Pharma Inc. in the US market


USFDA lifts clinical hold on submission of Covaxin
News | February 20, 2022

USFDA lifts clinical hold on submission of Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades


Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy
Drug Approval | February 20, 2022

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy

Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear


cbdMD becomes first American CBD brand to receive UK validation
Biotech | February 19, 2022

cbdMD becomes first American CBD brand to receive UK validation

The company will now be allowed to sell its proprietary and validated tinctures, gummies, and capsules across the UK


Fitch revises outlook on Jubilant Pharma to negative; affirms at 'BB'
News | February 19, 2022

Fitch revises outlook on Jubilant Pharma to negative; affirms at 'BB'

Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).


Amneal expands injectables portfolio with four new products
Drug Approval | February 19, 2022

Amneal expands injectables portfolio with four new products

Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market


UAE to recognise Indian pharma products within three months
News | February 19, 2022

UAE to recognise Indian pharma products within three months

The agreement also had a permanent safeguard mechanism which can be resorted to in a situation of sudden surge in imports.


US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022


AptarGroup reported 2021 sales at US $3.23 billion
News | February 18, 2022

AptarGroup reported 2021 sales at US $3.23 billion

AptarGroup acquired Voluntis and 80% of Weihai Hengyu Medical Products in 2021.