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1st Non-Antipsychotic OKd for Agitation in Alzheimers Patients

[ Price : $8.95]

FDA approves an expanded use for Axsome Therapeuticss Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) to trea...

FDA Panel Rejects Astrazenecas Camizestrant In Closely Watched Vote

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An FDA advisory committee votes 6 to 3 against supporting AstraZenecas investigational breast cancer therapy camizestrant.

Enrollment Halted in Newrons Schizophrenia Study After Patient Death

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Following a reported patient death, FDA places a hold on new patient enrollment at U.S. sites participating in ENIGMA-TRS 2 study,...

Prospective AI Versioning Standard Needed: Post

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A Clinical Trial Vanguard online post makes the case for further FDA guidance so drug trial sponsors can successfully incorporate ...

Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

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A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic...

Reviewers Brief ODAC on Camizestrant Concerns

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of A...

Celgene Cell Therapy Facility Hit with Form 483

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FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including defic...

GSK NDA Accepted for Hepatitis B Drug

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FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.

Insulet Class 1 Recall of Insulin Pump Components

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Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death.

8 Observations on Fujifilm Diosynth FDA-483

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FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manuf...