Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 58
Drug Approval
Drug Approval | 23 May 2022

Vaxzevria approved in the EU as third dose booster against Covid-19

Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine

Drug Approval
Drug Approval | 23 May 2022

CHMP recommends European Commission approval of Rinvoq

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients

Drug Approval
Drug Approval | 21 May 2022

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date

Drug Approval
Drug Approval | 20 May 2022

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million

Drug Approval
Drug Approval | 19 May 2022

Biocon Biologics and Viatris launch Abevmy in Canada

Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020

Drug Approval
Drug Approval | 19 May 2022

CDSCO approves Jardiance for heart failure with preserved ejection fraction

With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction

Drug Approval
Drug Approval | 18 May 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series

Drug Approval
Drug Approval | 18 May 2022

Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India

Bempedoic Acid administered as a 180-mg dose, is approved by the USFDA and European Union for the treatment of hypercholesterolemia

Drug Approval
Drug Approval | 18 May 2022

Themis Medicare gets add on approval for Viralex

Viralex (Inosine Pranobex) is an immunomodulatory agent with broad-spectrum antiviral properties

Drug Approval
Drug Approval | 17 May 2022

RadNet’s AI subsidiaries obtain USFDA clearance for mammography and prostrate AI tools

Quantib Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist's reading station

Drug Approval
Drug Approval | 15 May 2022

USFDA approves novel, dual-targeted treatment for type 2 diabetes

In clinical trials, treatment proved more effective than other therapies evaluated

Drug Approval
Drug Approval | 14 May 2022

Zydus launches Bemdac to treat LDL-Cholesterol

It is a new class of drug that treats uncontrolled LDLCholesterol, despite the use of a maximum tolerated dose of statins

Drug Approval
Drug Approval | 12 May 2022

OvaCis rapid test to detect ovarian cancer gets CE mark

Revolutionary ovarian cancer rapid test available Q4 2022

Drug Approval
Drug Approval | 12 May 2022

USFDA approves Lilly and Incyte's Olumiant to treat hospitalised patients with Covid-19

Olumiant is the first and only JAK inhibitor USFDA-approved for the treatment of Covid-19

Drug Approval
Drug Approval | 11 May 2022

Alembic Pharmaceuticals receives USFDA approval for Arformoterol Tartrate

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies

Drug Approval
Drug Approval | 09 May 2022

Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate

Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA

Drug Approval
Drug Approval | 06 May 2022

USFDA clears Abbott’s test to detect four sexually transmitted infections simultaneously

Abbott's multiplex test runs on its most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes – detecting four infections simultaneously

Drug Approval
Drug Approval | 06 May 2022

Lupin receives USFDA approval for Pregabalin and Iloperidone

While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility

Drug Approval
Drug Approval | 06 May 2022

Zydus receives tentative approval from USFDA for Selexipag tablets

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

Drug Approval
Drug Approval | 04 May 2022

Eugia Pharma receives USFDA approval for Bortezomib

The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA

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