The Manila Times on MSN1d
FDA set to reduce drug registration timelineTHE Food and Drug Administration (FDA) said Friday that it is set to release a new administrative order that would reduce the timeline of drug registration, especially among imported drugs that have ...
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter.
Gov. Newsom in 2020 signed a law allowing California to manufacture its own insulin, an effort to bring down the cost of the ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Zunveyl, an oral medication, is a better-tolerated version of galantamine for managing mild to moderate Alzheimer's symptoms.
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