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The Latest Breaking News from Food and Drug Administration

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

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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

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

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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

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.

Tribune News Service

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.

WEKU

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

The Independent UK

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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.

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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.

Bangkok Post

NVI plans to utilise local booster shots

The National Vaccine Institute (NVI) plans to use locally developed Covid-19 vaccines as booster shots when they are completed and approved by the Food and Drug Administration (FDA).

Orlando Sentinel

Ketamine ‘saved my life’: Depressed, anxious Floridians turn to unregulated psychadelics

ORLANDO, Fla. — Ashley Blanco, 27, has grappled with anxiety, depression and obsessive-compulsive disorder for the better part of a decade. Antidepressants and therapy didn’t help. After she graduated college, the COVID-19 pandemic hit. It sent her mental health to an all-time low.

Benzinga

Provention Bio's Second Try, Apellis's Eye Disorder Drug Review, 3 Adcom Verdicts And More: November's Key PDUFA Catalysts Biotech Investors Must Know

Editor's note: This story has been corrected to reflect that the FDA deferred action on Amicus Therapeutics' Biologics License Application.

Bangkok Post

Parents warned about Dragon's Breath sweet

The treat known as Dragon's Breath, a liquid nitrogen-based sweet, should be treated with caution as it can potentially cause frostbite, Thailand's Food and Drug Administration (FDA) has warned.

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