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Sunday, October 12, 2025
TopicFDA

Topic: FDA

US FDA takes new dengue vaccine by Japanese firm Takeda for priority review

Takeda has carried out phase 3 trials of the vaccine candidate and found it to be 80.2% effective in preventing symptomatic dengue cases after a year of vaccination.

‘No prescription sought, drugs under different names’ — Maharashtra FDA busts ‘abortion pill racket’

FDA officers in 13 parts of the state posed as customers and managed to easily procure the kits. FIRs lodged against e-commerce app, ‘unlicensed’ agency.

US rejection of emergency use for Covaxin will not impact India’s vaccination drive: Govt

NITI Aayog member V K Paul said that he respected US' decision and hoped that the vaccine manufacturer will comply with the parameters of their regulatory system.

US FDA approves first new Alzheimer’s drug in 20 years despite warnings from experts

The new drug, which Biogen developed with Japan's Eisai Co., did not reverse mental decline, but only slowed it in one study. The drug is given as an infusion every four weeks.

US FDA authorises Johnson & Johnson single dose vaccine

President Joe Biden described the approval as an encouraging development in efforts to end the Covid-19 crisis and said this is exciting news for all US citizens.

US pet food company recalls products after 70 dogs die due to suspected poisoning

US FDA noted that all cat and dog products from Midwestern Pet Foods may contain high levels of aflatoxin that could have been behind the deaths.

Pfizer to seek emergency US FDA authorisation for its Covid vaccine today

Shown to be 95% effective, Pfizer's vaccine could be the first to be cleared for use, but before that, it must clear the FDA's thorough vetting process, which could take at least 3 weeks.

Antibiotic Teicoplanin 10 times more effective than Covid drugs like HCQ, says IIT Delhi study

Teicoplanin is an FDA-approved glycopeptide antibiotic, which is regularly used for treating Gram-positive bacterial infections with low toxicity profile in humans.

Covid vaccine to be widely available in the US by April, CDC chief says

About 700 million vaccine doses should be available by April. The vaccine candidates that are furthest along in development will need a two-dose regimen, CDC chief Redfield said.

US FDA is setting a higher bar for emergency Covid vaccine approvals

FDA says it will need more robust data about how well a Covid vaccine works before granting an emergency waiver, building on guidelines that say it should be at least 50% effective.

On Camera

If fundamental right to property can be taken away, so can all the others: AG Mulgaokar

If this step even partially achieves its desired results, there will be so much dislocation in the country’s economic structure as to prove a national calamity, advocate AG Mulgaokar wrote in 1969.

Niti Aayog recommends fully decriminalising 12 offences under new I-T Act to ‘foster more trust’

Recommendations appear in Niti Aayog’s Tax Policy Working Paper Series–II. It says there is a need to shift away from fear-based enforcement to trust-based governance.

India, UK sign £350 mn deal for Martlet. What are these Lightweight Multirole Missiles

In service with the British military since 2019, it is also known as the Martlet missile. Ukrainians have also deployed these missiles against Russian troops.

CJI, IPS, IAS & Homebound: A wake-up call 75 years in the making

Education, reservations, govt jobs are meant to bring equality and dignity. That we are a long way from that is evident in the shoe thrown at the CJI and the suicide of Haryana IPS officer. The film Homebound has a lesson too.