ChemoCentryx's Avacopan, gets U.S. FDA approval for treating rare autoimmune disease

Highlights

• Avacopan gets approval from US FDA
• This drug is used to treat antineutrophil cytoplasmic antibody associated vasculitides

ChemoCentryx Inc, lead drug for treating a rare, fatal autoimmune disease has been approved by the U...

Australian firm Ellume recalls at least 200,000 at-Home Covid-19 test kits, over false positives

Highlights

• Ellume recalls almost 200,000 at-home Covid-19 tests from the US
• The US FDA issued an alert on Tuesday

Ellume, an Australian medical tech manufacturer has recalled almost 200,000 at-home Covid-19 tests. These kits have bee...

US FDA approves Pfizer's covid-19 vaccine

Pfizer’s corona virus vaccine gets complete authorization. This is a two-dose vaccine, and the two jabs are given three weeks apart from each other.

Janet Woodcock, the Commissioner of FDA said that, people can be very confident about the effectiveness...

US FEDERAL HEALTH OFFICIALS SAYS ASTRAZENECA MAY HAVE USED OUTDATED DATA IN COVID-19 VACCINE TRIAL

Highlights

• In a statement issued on late Monday, the Data and Safety Monitoring Board said that it was concerned that the UK-based drugmaker may have provided an incomplete view of the efficacy data

• AstraZeneca had published the first data from an interim safety ...

JOHNSON & JOHNSON COVID VACCINE AUTHORIZED BY THE US FOR EMERGENCY USE

Highlights

• Courtesy of this approval, Johnson & Johnson's shot became the third vaccine to battle the COVID-19 pandemic in the United States

• President Joe Biden in his statement said that “This is exciting news for all Americans, and an encouraging ...

ALEMBIC PHARMA UNIT UNDER THE SCANNER OF US FDA FOR QUALITY CONTROL & EQUIPMENT ISSUES

Highlights

• The US FDA had recently issued a ‘Form 483’ to the Karkhadi unit of Alembic Pharma with five observations

• The FDA issues a ‘Form 483’ in which its inspectors enlist violations of good manufacturing practices by them at the time ...

US FDA GRANTS EMERGENCY USE AUTHORIZATION TO ELI LILLY'S ANTIBODY COCKTAIL FOR COVID-19

Highlights

• The company has said that the new treatment adds etesevimab or LY-CoV016 to bamlanivab or LY-CoV555, which has already been authorized, in order to make a double-antibody version

• Similar kind of dual antibody-cocktail is already available in the market...

DISTRIBUTION OF MODERNA’S COVID-19 VACCINE STARTS IN THE U.S.

Highlights

• Days after receiving emergency use authorization (EUA) from the US Food and Drug Administration (FDA), the distribution of the COVID-19 vaccine developed by Moderna Inc. has already started

• As per Moncef Slaoui, Chief of Operation Warp Speed, the first...

Pfizer SEEKING THE EMERGENCY USE TAG FROM THE U.S. FOR ITS COVID-19 VACCINE

Highlights

• If the emergency use tag is granted, the COVID-19 vaccine is likely to be available as early as next month said Pfizer

• The decision now lies with the US Food and Drug Administration (FDA) in order to permit the emergency use of the vaccinations