For individuals 60 and older, RSV vaccination is advised by FDA specialists. Future plans

The second of two new vaccines intended for persons 60 and older to avoid serious illness was declared safe and effective for older adults on Wednesday by a Food and Drug Administration advisory panel. The RSV vaccine is still being reviewed by the agency. The FDA commissioner must still provide ...

The Centers for Disease Control and Prevention (CDC) warns that minorities are disproportionately likely to require hospitalization due to the flu.

An investigation by the FDA showed that some communities of color had greater rates of hospitalization due to the flu while having lower vaccine coverage.

A potentially severe flu season has federal health experts advocating for increased vaccine coverage among racial and ethnic minorit...

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 FDA REJECTS OCUGEN’S REQUEST FOR EMERGENCY USE AUTHORISATION FOR COVAXIN

Highlights

• The Hyderabad-based company said that the BLA path is for full approval instead of emergency use authorization and all applications have to follow the BLA process

• Few weeks back, Ocugen, had submitted a "Master File" to the US Food and Drug A...

BIOGEN'S ALZHEIMER’S DRUG RECEIVES APPROVAL FROM US FDA

In a historic move, the U.S. Food and Drugs Administration (FDA) on Monday granted approval to Biogen Inc's Aducanumab, a drug which happens to be the first against the Alzheimer's disease.
This new drug Aducanumab, that was heavily criticised by a certain section of medical expert...

TO PREVENT FUTURE PANDEMIC, THE WORLD NEEDS CHINA’S COOPERATION: U.S.

Highlights

• Scott Gottlieb, said the information to support the theory that SARS-CoV-2 virus may have escaped from a lab in Wuhan, China has increased

• Hotez, said that the world is at risk of future outbreaks as it is still unaware of how the pandemic started

US FDA GRANTS EUA TO GSK'S DRUG THAT TREATS MILD COVID-19 IN PEOPLE ABOVE 12

Highlights

• The GSK said this drug called VIR-7831 or Sotrovimab was cleared by the U.S. Food and Drug Administration for people ageing over 12 

According to the statement issued by drugmaker GSK, the US FDA has granted Emergency Use Authorisation to a drug called S...

OCUGEN, BHARAT BIOTECH'S AMERICAN PARTNER SUBMITS MASTER FILE ON COVAXIN TO THE US FDA

Highlights

• Ocugen has submitted a "Master File" to the US Food and Drug Administration before seeking an emergency use authorisation (EUA) in the United States

• The Bharat Biotech told the government of India that it has already submitted 90% of document...

PFIZER, BIONTECH TO APPLY FOR FULL US REGULATORY APPROVAL FOR THEIR COVID-19 VACCINE

Highlights

• Pfizer and BioNTech in a press release on Friday said they plan to submit data backing the application on a rolling basis over the coming weeks to the Food and Drug Administration (FDA). 

• Pfizer Chief Executive Albert Bourla said “We are pro...

FORMER FDA COMMISSIONER GOTTLIEB SAYS US TRAVEL BAN STRATEGY DOESN’T MAKE SENSE

Highlights

• Gottlieb said “I’m not sure what we are hoping to accomplish. If the goal is to try to prevent the introduction of virus into the U.S., there’s plenty of virus here.”

According to former FDA commissioner Scott Gottlieb, the travel ban ...

BAN ON MENTHOL CIGARETTES PROPOSED BY US FDA

Highlights

• The FDA said it is working toward issuing proposed product standards within the next year to ban menthol as a flavor in cigarettes and ban all flavors in cigars

• As per the experts, this ban is likely to take years to implement amid possible legal chall...

ONLY 77 OUT OF OVER 87 MILLION VACCINATED PEOPLE IN US DIED FROM COVID-19

Highlights

• The United States has witnessed total 32,875,045 coronavirus infected people till date, which happens to be the highest in the world

• As per the data collected by the CDC, vaccines bring down the risks of hospitalisation and deaths in COVID-19 cases

THIS IS WHY US LIFTED PAUSE OF JOHNSON & JOHNSON'S COVID-19 VACCINE

Highlights

• This pause came in effect after more than six cases of a rare and severe type of blood clot were reported in people those received the jab

• In a statement issued jointly, the two agencies said that use of the Janssen COVID-19 Vaccine should be resumed i...

U.S. HEALTH AGENCIES LIFT PAUSE ON JOHNSON & JOHNSON'S COVID-19 VACCINE AFTER SAFETY REVIEW

Highlights

• This review included two meetings of the CDC's Advisory Committee on Immunization Practices, the US Food and Drug Administration and the US Centers for Disease Control and Prevention

• According to the FDA, the available data showcases that the vacci...

AS REPORTS OF BLOOD CLOTS RISE, U.S. RECOMMENDS PAUSE ON JOHNSON AND JOHNSON'S COVID-19

Highlights

• According to the statement, until April 12, over 6.8 million doses of the J&J vaccine have been administered in the country of the United States

• With the number of casualties related to COVID-19 heading speedily towards 1 million-mark, the United S...

US FDA GIVES CLEARANCE TO MODERNA TO SPEED UP OUTPUT OF ITS COVID-19 VACCINE

Highlights

• The US Food and Drug Administration (FDA) on Friday granted clearance to Moderna to speed up output of its coronavirus vaccine by allowing it fill a single with nearly 15 doses

• Moderna said the vaccine developed by it now can be supplied in vials conta...

BATCH OF J&J’S COVID-19 FAILS US FDA QUALITY STANDARDS

Highlights

• The Emergent BioSolutions factory involved had not yet been approved by the US FDA to make part of the vaccine said Johnson and Johnson

• The United States President Joe Biden recently announced his plans of securing another 100 million doses of COVID-19...

US FDA GRANTS EMERGENCY USE AUTHORISATION TO AMAZON'S COVID-19 TEST KIT

Highlights

• Amazon is now planning to use the real-time RT-PCR Test for detecting SARS-CoV-2. This is also part of it's overall preparedness and response programme

• “Amazon real-time RT-PCR test for detecting SARS-CoV-2 will be performed at laboratories d...