fda-and-biotech News
Outlook Therapeutics Stock Tumbles After FDA Rejects Key Eye Drug Again
The U.S. regulator has issued a second Complete Response Letter for the company's wet AMD treatment, ONS-5010, requesting additional efficacy data and clouding its U.S. market ambitions.
Elanco Shares Rise on USDA Approval for New Canine Dermatitis Drug
The new treatment, Befrena, positions Elanco to challenge rivals in the lucrative $1.3 billion U.S. pet dermatology market, marking another key win for its companion animal pipeline.
Axsome Stock Hits Record High on Dual FDA Boost for Pipeline Drugs
Shares surge over 18% after the FDA grants Priority Review for its Alzheimer's agitation drug and supports a regulatory filing for its narcolepsy treatment.
Corcept Plunges 47% After FDA Rejects Key Cushing's Syndrome Drug
Regulator issues a Complete Response Letter for relacorilant, demanding more data despite the drug meeting its main goals in a pivotal Phase 3 trial.
Corcept Plunges After FDA Rejects Key Cushing's Syndrome Drug
Shares fall over 12% as U.S. regulators issue a Complete Response Letter for relacorilant, citing an unfavorable benefit-risk profile and demanding more data.
Axsome Rallies as FDA Clears Path for Narcolepsy Drug Filing
Shares trade near 52-week highs after positive agency feedback supports a New Drug Application submission for its narcolepsy treatment, AXS-12, planned for early 2026.
Axsome Soars on Dual FDA Wins for CNS Drug Pipeline
Shares climb after company announces positive pre-NDA meeting for its narcolepsy drug and secures Priority Review for its Alzheimer's agitation treatment.
Vanda Pharma Soars on FDA Approval for First New Motion Sickness Drug in 40 Years
NEREUS™ (tradipitant) approval marks a major milestone, targeting a market estimated at $670 million, though shares dip in a 'sell the news' reaction.