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Monday, September 27, 2021

Food and Drug Administration (FDA)

FOOD AND DRUG ADMINISTRATION (FDA) NEWS

US FDA authorizes third dose of Pfizer Covid-19 vaccine for older Americans

September 23, 2021 11:04 am

The booster dose is to be administered at least six months after completion of the second dose, and the authorization would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.

FDA pushes for Moderna booster shot data in weighing dose

September 04, 2021 12:10 pm

In particular, the FDA is looking for more information on the efficacy of a 100-microgram dose.

US health regulators have authorized extra Covid vaccines for those with weak immune systems

August 13, 2021 9:55 am

There's little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection.

Explained: How an unproven Alzheimer’s drug got approved

July 22, 2021 8:21 am

In announcing its approval in June, the FDA acknowledged there was not sufficient evidence that the drug would help patients. Instead, it said it was greenlighting Aduhelm under a program called “accelerated approval.”

Fake mucormycosis drugs seized after FDCA raids in Ahmedabad and Surat

July 07, 2021 11:24 pm

The FDCA has initiated an inquiry after Cuvicon brand of fake Posaconazole tablets and oral suspension concoctions used to treat mucormycosis were seized.

Eisai's drug for Alzheimer's with Biogen gets breakthrough status in US

June 24, 2021 7:29 am

The drug works in a similar manner to Biogen's Aduhelm, which was approved earlier this month.

Dual-antibody therapy effective against Covid-19 variants in animal study

June 22, 2021 2:56 pm

The study, published on Monday in the journal Nature, suggests that many, but not all, therapies made from combinations of two antibodies are effective against a wide range of variants of the virus in mice and hamsters.

Maharashtra FDA books 133 persons for illegally selling Covid-19 drugs

June 11, 2021 10:46 pm

Most of the offences were for illegal selling of Remdesivir injection while two offences were registered for selling Tocilizumab injection.

Man arrested for making fake Covid drugs in Meerut lab

June 07, 2021 10:46 pm

The police are now interrogating the accused, Sandeep Mishra, to find out for how long he has been making the fake drugs.

Moderna seeks full FDA approval for its vaccine

June 01, 2021 8:34 pm

Moderna announced Tuesday it has begun a rolling submission to the Food and Drug Administration of data from its studies of the two-dose vaccine.