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Covid-19

FDA advisory committee votes unanimously in favor of a one-shot

The U.S. Food and Drug Administration’s key science advisory panel, the Vaccines and Related Biological Products Advisory Committee, met on Jan. 26, 2023, to chart a path forward for COVID-19 vaccine policy. During the all-day meeting, the 21-member committee discussed an array of weighty issues including the efficacy of existing vaccines, the composition of future […]

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US

New Oreo LTO taps into the ‘metaverse’

EAST HANOVER, NJ. — Mondelez International, Inc.’s Oreo brand is launching a limited-edition sandwich cookie called the Most OREO OREO. The LTO features two chocolate wafer cookies sandwiched around a double-stuffed crushed-Oreo-crème filling. Marketed as being a “meta” Oreo, the company also is introducing a partnership with culinary personality Martha Stewart and an interactive website […]

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Business

FDA says Covid vaccines will probably get an annual update but

Justin Sullivan | Getty Images The Food and Drug Administration has laid out a road map for what Covid-19 vaccination may look like moving forward. In a briefing document published Monday, the FDA said the vaccines will probably need an annual update as the virus continues to evolve. The agency would select the Covid strain […]

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Gaming

FDA clears Wandercraft’s exoskeleton for stroke patient rehab |

Stroke patients in the US could soon take advantage of cutting-edge robotics during the recovery process. The Food and Drug Administration has cleared Wandercraft’s Atalante exoskeleton for use in stroke rehabilitation. The machine can help with intensive gait training, particularly for people with limited upper body mobility that might prevent using other methods. The current-generation […]

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Business

The benefits and risks of personal medical monitoring on the

A blood glucose control system with the help of a smartphone and a meter that is fixed to the skin. Ute Grabowsky | Photothek | Getty Images The internet of things to remote monitor and manage common health issues has been growing steadily, led by diabetes patients. About one out of every 10 Americans, or […]

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Science

FDA Approves New Alzheimer’s Drug Designed to Slow Cognitive

​The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report […]

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US

House investigation says FDA approval process of Alzheimer’s drug

CNN  —  A congressional investigation found that the US Food and Drug Administration’s “atypical collaboration” to approve a high-priced Alzheimer’s drug was “rife with irregularities.” The report, released Thursday, was the result of an 18-month investigation by two House committees. It is sharply critical of Biogen, maker of the medication Aduhelm. The report says Biogen […]

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Business

FDA changes Plan B packaging to clarify that it is not an

In this photo illustration, PlanB one-step emergency contraceptive is displayed on June 30, 2022 in San Anselmo, California. Justin Sullivan | Getty Images The Food and Drug Administration is changing the informational packaging of the emergency contraceptive pill, Plan B One-Step, to clarify that it is not an abortion pill, the federal agency announced Friday. […]

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PR

FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecif…

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is […]

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Business

FDA expected to decide on Pfizer RSV vaccine for older adults by

The Food and Drug Administration is expected to decide by spring whether to approve Pfizer’s vaccine to prevent respiratory syncytial virus, or RSV, in adults ages 60 and older. Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by […]