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The Latest Breaking News from Food and Drug Administration

FDA suit accuses Florida company of making and selling ‘adulterated’ drugs

The Food and Drug Administration has filed a lawsuit accusing a Boca Raton pharmaceutical manufacturer of selling “adulterated” drugs and failure to correct violations cited by the FDA in 2018.

Tribune News Service

FDA decision could increase access to abortion pills across Alaska

A new federal rule change could make it easier for Alaskans to access medical abortions, especially in rural communities.

Tribune News Service

How Novo Nordisk Just Expanded Its Diabetes Lead Over Pfizer, Eli Lilly

The Food and Drug Administration expanded the label for Novo Nordisk's oral diabetes medicine, leading NVO stock to jump Friday.

Investors Business Daily

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What the FDA's accelerated approval of a new Alzheimer's drug could mean for those with the disease – 5 questions answered about lecanemab

The U.S. Food and Drug Administration approved the medication lecanemab, sold under the brand name Leqembi, on Jan. 6, 2023, through an “accelerated approval pathway” that fast-tracks promising clinical treatments for diseases in which there are no other currently effective options.

The Conversation

A new Alzheimer’s drug has been approved. What to know about lecanemab

A new drug that appears to slow early Alzheimer’s disease is coming to the market.

Tribune News Service

Mayo Clinic expert provides perspective on FDA approval of another experimental Alzheimer's drug

The Food and Drug Administration granted accelerated approval of a disease-modifying treatment that could potentially give some patients with Alzheimer's disease something they haven't had before: a medication that may slow the decline of memory and thinking.

Tribune News Service

Editorial: The FDA is right to allow pharmacies to distribute abortion medication

Precisely when human life begins is above our pay grade, but at a time when states are radically restricting women’s right to seek reproductive health care — and forcing rape and incest victims, among others, to give birth — policymakers in Washington ought to be wisely using the levers of…

Tribune News Service

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US Approves New Drug to Treat Alzheimer's Disease

The US Food and Drug Administration 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…

Asharq Al-Awsat

Abortion pills should be easier to get. That doesn't mean that they will be

Changes by the FDA mean patients won't have to schedule in-person exams to get a prescription. That opens the door for more pharmacies to provide the medication. But not everyone will have access.

WEKU

Walgreens confirms plans to sell abortion pills under new FDA rules

Walgreens expects to offer abortion pills after the Food and Drug Administration changed its rules for the drug.

Tribune News Service

Taiwan rejects tonnes of 'toxic' crabs from China

Taiwanese health officials have rejected a 6,400-kilogramme shipment of live crabs from mainland China, citing toxins in the popular seafood — the first time that island authorities have identified a food-security issue with the crabs in the past two years.

Bangkok Post

Abortion pills can be sold at US pharmacies, the Food and Drug Administration rules

Activists hail the move as ‘a step in the right direction’

The Independent UK

The FDA finalizes rule expanding the availability of abortion pills

The Food and Drug Administration on Tuesday finalized a rule change that broadens availability of abortion pills to many more pharmacies, including large chains and mail-order companies.

WEKU

Probe: Alzheimer's drug approval 'rife with irregularities'

The Food and Drug Administration's contentious approval of a questionable Alzheimer's drug is taking another hit

The Independent UK

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Tribune News Service

House report questions FDA’s approval of Alzheimer’s drug

WASHINGTON — A joint investigation released Thursday by House Democrats identified unusual collaboration between Food and Drug Administration officials and drugmaker Biogen, highlighting potential problems in the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

WEKU

FDA changes Plan B label to clarify 'morning-after' pill doesn't cause abortion

The agency in a memo Friday said the emergency contraception pills are not the same as abortion pills — which end a pregnancy — a fact that has long been understood in the medical community.

The Independent UK

FDA changes Plan B label, clarifies it won't cause abortion

The Food and Drug Administration announced Friday that it will overhaul packaging labels for the emergency contraceptive pill, Plan B, that women can take after having sex to prevent a pregnancy

Investors Business Daily

Gilead Sciences Snags FDA Approval For Twice-Yearly HIV Shot

Gilead won Food and Drug Administration approval for a twice-a-year HIV treatment called Sunlenca on Thursday.

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The Independent UK

ALS patients contend with $158K price tag on new drug

For two years, Becky Mourey pushed the Food and Drug Administration to approve an experimental drug for her Lou Gehrig’s disease

The Guardian - US

Onslaught of new abortion restrictions looms in reddest of states

New state legislative sessions likely to bring fresh efforts to restrict, penalize or altogether ban the procedure

WEKU

A major drugmaker plans to sell overdose-reversal nasal spray Narcan over the counter

Emergent BioSolutions has applied to the Food and Drug Administration to sell the opioid overdose-reversal drug over the counter. Addiction experts say it may be a key step to lower fentanyl deaths.

Tribune News Service

A new drug appears to slow Alzheimer’s. Here’s what to know

An experimental drug appears to slow cognitive decline in people with early onset Alzheimer’s.

The Independent UK

Speedier drug approvals hit slowdown as FDA faces scrutiny

The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs

Tribune News Service

Editorial: Thicker than sexuality: Let gay and bisexual men donate blood like anyone else

The Food and Drug Administration is on the cusp of changing rules so that more gay and bisexual men can donate blood like anyone else. It’s about time.

WEKU

Study: Alzheimer's drug shows modest success slowing declines in memory, thinking

In a large study, the experimental Alzheimer's drug lecanemab reduced the rate of cognitive decline by 27 percent in people in the early stages of the disease.

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