The agency announced moves to cut regulatory obstacles for the makers of biosimilar drugs, which are akin to generics and may help lower drug costs.
Category: Food and Drug Administration
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Texas Sues Tylenol Makers, Claiming They Hid Autism Risks
The lawsuit follows claims by President Trump that linked use by pregnant women of acetaminophen to autism, a connection that is unproven.
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Neutrogena Recalls Makeup Wipes Over Bacterial Contamination Concerns
The recalled wipes were distributed in Florida, Georgia, South Carolina and Texas, according to the Food and Drug Administration.
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Drug With a 30-Year Monopoly Is Target of State-Level Push to Curb Prices
In a first, Colorado will cap the price of Enbrel, an arthritis drug. Using patent tactics, the drugmaker Amgen has aggressively blocked competition for it.
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Trump Rattles Vaccine Experts Over Aluminum
The president’s call for removal of the metal from childhood inoculations set off alarms. About half of shots for polio, whooping cough and other diseases would be affected.
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F.D.A.’s Approval of Drug for Autism Upends Review Process
The agency revived an old treatment for cancer patients, unilaterally approving it for a subset of people with autism. Experts worry that the narrower scope will get lost in the hype.
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FDA OKs New Keytruda Shot for Cancer
The F.D.A. approved Merck’s injected version of its blockbuster infusion Keytruda. The company says it will be quicker and easier, but it stands to slow the adoption of cheaper competitors and increase costs by billions of dollars.
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F.D.A. Reviews Cases of Covid Vaccine Deaths
The agency plans to present accounts of deaths involving children and birth defects to an influential C.D.C. panel meeting next week.
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Trump Weighs Crackdown on Medicines From China
Behind the scenes, major pharmaceutical companies and Trump-tied billionaires are furiously lobbying in opposite directions over proposed anti-China measures.
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F.D.A. Official Overruled Scientists on Wide Access to Covid Shots
The agency’s staff scientists pointed out how Covid was still unpredictable and posed a threat to toddlers, but the official decided to restrict shots only to children with risk factors.
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CVS Holds Off on Offering Covid Vaccines in 16 States
The country’s largest pharmacy chain said it needed a C.D.C. panel to recommend the shots before it could offer them nationwide.