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Safety Labeling Changes Guidance

[ Price : $8.95]

FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes a...

Committee Advances Pediatric Voucher Reauthorization

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The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Revie...

FDA OKs Expanded Labeling for Asthma Drug

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FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% red...

sGERD Drug Development Guidance

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FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux d...

J&J Reports Positive Data in Psoriasis Drug

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Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis dr...

Exactech Pays $8 Million in Whistleblower Cases

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The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whistleblowers allegations that th...

Are FDA Advisory Committees Doomed?

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FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of ad...

AstraZeneca Fasenra Trial Misses in COPD

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AstraZeneca reports that data from a Phase 3 trial of Fasenra (benralizumab) did not achieve the primary endpoint in patients with...

Developing Disseminated Coccidiodomycosis Drugs

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FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.

Lillys Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial

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Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisks...