Food And Drug Administration

FDA plans to use AI to speed drug approvals and review food chemicals under new priorities

Agency’s new road map aims for faster approvals and healthier food, but some experts caution AI is not yet up to the task.

US' FDA adds Merck pill as 2nd easy-to-use drug against COVID-19

The Food and Drug Administration authorization comes one day after the agency cleared a competing drug from Pfizer.

FDA expands Pfizer COVID booster, opens extra dose to age 16

On Thursday, the Food and Drug Administration gave emergency authorization for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech -- if it’s been six months since their last shot.

FDA approves much-debated Alzheimer's drug panned by experts

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

US Calls for Pause on Johnson & Johnson Vaccine After Clotting Cases

Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.

US Senate confirms Scott Gottlieb FDA commissioner

Gottlieb, a physician and former deputy FDA commissioner during the George W. Bush administration, is seen as competent and knowledgeable. But critics worry about his ties to the pharmaceutical industry.

Chinese drug approval boosts AstraZeneca's lung cancer hopes

Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker's prospects in a key therapy area.

FDA Woes: Pharma Companies feel the US FDA heat

The US drug regulator off late, has been a cause of headaches for many domestic pharmaceutical companies. Today, shares of Divis Laboratories tanked 20 percent after an import alert was issued its on Vizag unit. The Dr Reddy's Laboratories shares also hit a 52-week low after the company's Duvvada plant received 13 observations which included repeats from a November, 2015 warning letter.

Glenmark rises 4% on receipt of inspection report from US FDA

The drug firm received establishment inspection report (EIR) from the US Food and Drug Administration on closure of inspection of its Ankleshwar plant in Gujarat.

Alembic Pharma soars 7% on USFDA inspection clearance

The US drug regulator had inspected its Baroda unit between March 6 and 10 and issued no Form 483s for the same.

Glenmark's blood pressure drug gets US FDA nod; shares up 1%

The US drug regulator gave a tentative nod for the company's Olmesartan Medoxomil tablets, which is used to treat blood pressure.

Lupin to see approvals after US FDA gives clean chit: Macquarie

Of the total 18 observations, 9 from July 2015 and another 9 from March 2016 inspection, the former ones relating to equipment and warehousing have been closed. Nine observations are still outstanding for the company.

Here are Sanjiv Bhasin's top trading ideas

In an interview to CNBC-TV18, Sanjiv Bhasin of IIFL shared his reading and outlook on the market.

Upbeat on IPCA; buy stock on domestic growth: Nomura

This is depite the fact that exports revival in its US and institutional businesses seems distant as the US- Food and Drug Administration (FDA) regulatory issues are likely to remain unresolved in the next two years.

Aspire to hit $5 bn in sales soon; focus on specialty biz: Lupin

The Lupin Pharmaceuticals duo MD Nilesh Gupta and CEO Vinita Gupta say current business conditions only permit revenue visibility of USD 3.5 billion, although their aspiration is to hit USD 5 billion soon. They are among the 50 contenders vying for the World Entrepreneur Award currently being hosted by E&Y at Monte Carlo.

US FDA issues in pharma space may end soon: Morgan Stanley

Sameer Baisiwala, pharmaceutical and property analyst at Morgan Stanley, feels pharmaceuticals space is a good bet given the recent EIRs issued to domestic pharma companies by the regulator.

181 food licences in Thane cancelled for FDA rule violation

Of the total food samples inspected last year, 105 were found to be sub-standard and 30 unfit for human consumption.

Ex-Ranbaxy promoters fined $400mn for hiding info from Daiichi

Malvinder and Shivinder Singh had sold their stake in Ranbaxy Laboratories to Daiichi way back in 2008, following which Daiichi-led Ranbaxy was forced to pay the US Department of Justice a sum of USD 500 million over non-compliance with US Food and Drug Administration's testing norms.

Thermo Fisher Scientific Receives FDA Clearance for New Allergen Component Tests for Hazelnut, Walnut and Cashew Nut IgE Sensitization

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it has received 510(K) clearance from the U.S. Food and Drug ...

Govt to launch Bedaquiline,1st TB drug approved by FDA in 40 yrs

Bedaquiline, known as the 'miracle drug' is the first TB drug to be approved by Food and Drug Administration (FDA) in over 40 years. The drug will be made available in six public hospitals in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad.

Sun Pharma gains; launches Imatinib Mesylate in US market

The company's subsidiary has received final approval for Imatinib Mesylate from Food and Drug Administration (FDA) in December 2015.

See China growth slowing to 5.5%; liquidity drying: Nomura

Prabhat Awasthi, head of India equities, Nomura, says Bank of Japan's move to go into negative interest rate zone was more of a rate signal and not a liquidity tool for markets

Buy Glenmark Pharma; like Lupin, Dr Reddy's Lab: Abhishek Sharma

Abhishek Sharma, Pharma Analyst at IIFL recommends buying Glenmark Pharma and likes Lupin and Dr Reddy's Labs.

Lupin gets FDA approval for generic Femhrt tablets

The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement. "Lupin's US subsidiary, Lupin Pharmaceuticals Inc shall commence promoting the product in the US shortly," it added.