Articles by Manas Mishra

Federal Investigators to Review FDA Response to Baby Formula Recall

Federal investigators have launched a review into whether the U.S. Food and Drug Administration properly inspected Abbott Laboratories’ Michigan plant and how the agency oversaw the baby formula recall that led to severe U.S. shortages. The review, which is expected …

FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine

The U.S. drug regulator on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics during a relentless …

J&J to Resume Shipments of COVID-19 Vaccine to EU with Safety Warning

Johnson & Johnson said on Tuesday it will resume rolling out its COVID-19 vaccine in Europe after the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots. Europe’s health regulator, …

FDA Halts Vaccine Manufacturing at Plant Where Doses Were Wasted

The U.S. Food and Drug Administration has asked Emergent BioSolutions Inc. to halt producing new materials for COVID-19 vaccines until the regulator completes an inspection of its plant in Baltimore, which is under scrutiny after millions of doses were thrown …

U.S. Recommends Pausing Use of J&J COVID Vaccine over Rare Blood Clots

U.S. federal health agencies on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine for at least a few days after six women under age 50 developed rare blood clots after receiving the shot, dealing a fresh setback to …

Seresto Defends Flea, Tick Collars for Dogs As Safe Amid Calls for Recall

Elanco Animal Health Inc said on Friday it was backing the safety of its popular pet collars to repel flea and ticks after a Congressional subcommittee asked for the product to be recalled following reports linking it to hundreds of …

Insurer Centene to Buy Magellan for $2.2 Billion to Expand Its Mental Health Services

Health insurer Centene Corp. said on Monday it has agreed to buy Magellan Health Inc. in a $2.2 billion deal including debt, looking to build up its mental health services as more Americans struggle with COVID-19-related behavioral and anxiety issues. …

Amazon, Berkshire, JPMorgan Closing Down Joint Healthcare Venture

The healthcare joint venture of Amazon.com Inc., Berkshire Hathaway Inc. and JPMorgan Chase & Co., will cease to exist at the end of February, it said on Monday. The move comes three years after the companies came together to form …

FDA Appears Close to Approving ‘Highly Effective’ Moderna COVID-19 Vaccine

Moderna Inc.’s COVID-19 vaccine appeared to be set for regulatory authorization this week after U.S. Food and Drug Administration staff members did not raise any major new concerns about it in documents released on Tuesday. The FDA reviewers said a …

U.S. Drug Advisory Panel Meets Today on Pfizer’s COVID Vaccine

A panel of outside advisers to the U.S. Food and Drug Administration is meeting on Thursday to weigh whether to recommend that the agency authorize Pfizer’s coronavirus vaccine for emergency use, one of the last steps before vaccinations could begin. …