Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 63
Drug Approval
Drug Approval | 25 February 2022

Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction

Drug Approval
Drug Approval | 23 February 2022

Zydus receives USFDA approval for Dapagliflozin tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad

Drug Approval
Drug Approval | 22 February 2022

UK MHRA approves Marksans All in One oral solution

Therapeutic use of the product is for short term symptomatic relief of colds, chills and influenza including chesty coughs

Drug Approval
Drug Approval | 21 February 2022

Strides receives USFDA approval for Amantadine Hydrochloride capsules

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

Drug Approval
Drug Approval | 20 February 2022

WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients

Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra

Drug Approval
Drug Approval | 20 February 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

Drug Approval
Drug Approval | 19 February 2022

Amneal expands injectables portfolio with four new products

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

Drug Approval
Drug Approval | 19 February 2022

EC approves Tepmetko to treat non-small cell lung cancer

Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment

Drug Approval
Drug Approval | 19 February 2022

US FDA to review Amylyx new drug application for AMX0035

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

Drug Approval
Drug Approval | 18 February 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

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

Drug Approval
Drug Approval | 17 February 2022

Swissmedic approves BeiGene's Brukinsa

With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain

Drug Approval
Drug Approval | 17 February 2022

USFDA approves Lupin’s Supplemental New Drug Application for Solosec

The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV

Drug Approval
Drug Approval | 15 February 2022

Avion Pharmaceuticals announces USFDA approval of DHIVY

Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing

Drug Approval
Drug Approval | 14 February 2022

Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19

Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data

Drug Approval
Drug Approval | 14 February 2022

WHO prequalifies first monoclonal antibody - tocilizumab – to treat Covid-19

The three prequalified products are manufactured by the originator company, Roche, but the listings should pave the way for more companies coming forward to seek WHO prequalification

Drug Approval
Drug Approval | 14 February 2022

Zydus gets 180 days of shared exclusivity for Roflumilast tablets

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad

Drug Approval
Drug Approval | 10 February 2022

USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences

Adds five years of market exclusivity on approval

Drug Approval
Drug Approval | 10 February 2022

Health Canada gives breakthrough approval for Dolphin Vagal Stim device to treat Covid-19

The vagus nerve is the longest nerve in the body that travels down from the brain to innervate and control breathing, stress levels and inflammation

Drug Approval
Drug Approval | 09 February 2022

Dr Reddy’s launch generic version of Vasostrict in the US

The Vasostrict brand market had U.S. sales of approximately US $ 878.5 million MAT for the most recent twelve months ending in December 2021 according to IQVIA Health

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