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Reckitt Benckiser Group PLC
US regulator warns Reckitt on baby formula manufacturing standards
...Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, said the regulator was “committed to identifying and acting on issues early to prevent any firms from reaching the...
August 31, 2023
Vivek Ramaswamy
Vivek Ramaswamy’s FDA ‘corruption’ claims disavowed by Roivant
...“There is a reason for safety testing and then testing for effectiveness....
September 3, 2023
FT Live
US Pharma and Biotech Summit
Strategies for innovation, pricing and access
Thursday, 16 MayNew York, NY, USA
Covid-19 vaccines
FDA approves new Covid-19 boosters from Pfizer and Moderna
...and Drug Administration said on Monday....
September 11, 2023
Medical science
US regulators approve first human pill derived from faecal matter
...Seres said approval of the first oral microbiota therapy by the US Food and Drug Administration would provide patients with new tool to fight C. difficile infections, which cause inflammation of the colon...
April 26, 2023
Medical science
Transplanted pig kidneys provide ‘life-sustaining’ functions in human for first time
...Locke believes that the US regulator, the Food and Drug Administration, should permit a Phase 1 clinical trial of kidney xenotransplants into living recipients to begin as soon as possible without insisting...
August 16, 2023
UK economy
Post-Brexit chemicals regime risks UK safety standards, warn environmental groups
...No company has so far applied for permission to use BPB in the UK or the EU, but it is registered with the US Food and Drug Administration....
December 16, 2021
FT Live
Global Pharma and Biotech Summit
Driving life sciences innovation in a disrupted world
Tuesday, 5 NovemberIn-Person & Online Conference
Dementia
Two Alzheimer’s drugs offer hope to patients after decades of waiting
...The US Food and Drug Administration in January approved lecanemab, a drug co-developed by Japanese drugmaker Eisai and US biotech Biogen, under an accelerated process....
May 8, 2023
Brooke Masters
The abortion pill case is a disaster for innovation everywhere
...More than 5mn women have used the pill in the US since Danco steered it through the Food and Drug Administration’s approval process in 2000 and a series of later decisions that gradually expanded access....
April 19, 2023
Agritech
Cultivated meat start-ups race to add products to the menu
...Valeti is now a step closer to fulfilling his promise thanks to a decision from the US Food and Drug Administration last month that Upside Meat’s chicken fillet was safe for human consumption....
December 17, 2022
Pharmaceuticals sector
US approves Alzheimer’s drug that slows rate of cognitive decline
...The US Food and Drug Administration on Friday said it had approved lecanemab under an accelerated approval process, describing the medication as “an important advancement in the ongoing fight” to effectively...
January 6, 2023
Robert Eiss
We must dismantle the barriers that GDPR creates for global science
...When data collected from patients cannot be exported, EU-based trial sponsors cannot submit evidence to third-country regulatory agencies, including the US Food and Drug Administration....
January 3, 2023
Pharmaceuticals sector
Swedish scientist behind Alzheimer’s drug has big ambitions
...Lecanemab could be approved in the US as early as January under the US Food and Drug Administration’s accelerated approval pathway....
December 2, 2022
FT Magazine
A controversial biotech and an unlikely anorexia treatment
...In 2015, they created the “Center of Mental Health Pathways And Support for Self-directed care”, Compass, as a non-profit and began meeting with academics in the field....
March 2, 2023
FT Magazine
Global sperm counts are falling. This scientist believes she knows why
...This year, the European Food Safety Authority recommended lowering the “tolerable daily intake” for BPA by a factor of about 20,000. (The European Medicines Agency is opposing the change.)...
June 22, 2023
US Food & Drug Administration
FDA halts UK group’s baby formula imports over ‘modified’ paperwork
...The Food and Drug Administration said it had halted a waiver allowing Global Kosher to ship infant formula to the US after the company “submitted to UK authorities an official letter issued by the FDA that...
August 1, 2022
FT Live
FTWeekend Festival: U.S. edition
Where the Financial Times weekend paper comes to life
Saturday, 4 MayThe REACH, at the Kennedy Center for the Performing Arts, F Street Northwest, Washington, DC, USA
FT Magazine
How a squad of MAGA warriors flush with cash turned on each other
...But in June, after several large studies suggested it was ineffective, the US Food and Drug Administration revoked its emergency authorisation....
July 20, 2023
Mpox
US declares public health emergency over rapid spread of monkeypox
...“It’s important to know that the overall safety and efficacy profile will not be sacrificed with this approach,” said Food and Drug Administration commissioner Robert Califf....
August 4, 2022
FT Magazine
A new ‘miracle’ weight-loss drug really works — raising huge questions
...The US Food and Drug Administration approved Wegovy for general use in June 2021. Wegovy arrived on the market amid a global obesity crisis....
July 14, 2022
The Big Read
How science is getting closer to a world without animal testing
...His company recently helped French pharmaceutical group Sanofi receive approval from the US Food and Drug Administration for a clinical trial to extend approval of an existing drug to a new disease, a rare...
August 14, 2022
Live news updates from May 6: Wall Street stocks suffer five-week losing streak, Sinn Féin on track for historic victory in Northern Ireland
US regulators limit use of J&J’s Covid vaccine for adults
...The US Food and Drug Administration said on Thursday an updated analysis of reported cases of thrombosis with thrombocytopenia (TTS) — a syndrome that can lead to blood clots in combination with low blood...
May 5, 2022
News in-depthBiotech
Revolutionary Crispr gene editing speeds from lab to treatment room
...In 2020, the US Food and Drug Administration rejected a haemophilia therapy from BioMarin, asking for more data, though it has since received a conditional approval in the EU....
August 19, 2022
Drugs research
Eli Lilly says obesity drug has similar results to weight-loss surgery
...the company would approach the US Food and Drug Administration about potential pathways for an earlier submission for regulatory approval....
April 28, 2022
US retail
US baby formula crisis spurs debate over lack of competition
...Bubs and Kendal are both pressing the US Food and Drug Administration to grant full approval for their formula following application processes that have been going on for years....
June 30, 2022
Brooke Masters
US baby formula crisis highlights risk of reshoring
...A Food and Drug Administration inspection last year revealed poor practices that failed to control microbial growth, and a whistleblower alleged shoddy record keeping and lax cleaning....
May 18, 2022
US trade
Mexican truckers blockade US border crossings in protest over checks
...Abbott said the additional inspections were aimed at stopping migrant smuggling and drug trafficking across the border, as well as increasing vehicle safety....
April 12, 2022

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