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FDA Hasnt Inspected Factory with Recalls: ProPublica

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A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multip...

Lykos to Appeal MDMA Drug Rejection

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After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the...

Loper Bright May End FDA Speech Ban: Attorney

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Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new...

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

Supreme Court Could Hit FDA Regulation: FDLI

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A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...

FDA Denies Most Parts of 4 Dental Amalgam Petitions

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FDA denies most elements in four Consumers for Dental Choice petitions seeking additional agency actions to stop or reduce amalgam...

Dr. Reddys Hit With Form-483 After API Inspection

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A recent inspection at Dr. Reddys Laboratories active pharmaceutical ingredient manufacturing plant in Middleburg, NY cites three ...

High-Risk Groups Should Avoid Amalgam Fillings: FDA

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FDA says it now recommends that people in seven high-risk categories refrain from exposure to dental mercury amalgam when possible...

Sandoz $195 Million Fine in Price Fixing Scheme

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Sandoz agrees to pay a $195 million criminal penalty under a deferred prosecution agreement in an ongoing generic drug price-fixin...

Panel Recommends Against Mercury-containing Amalgam

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FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away f...