Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts

Arvelle Therapeutics acquires exclusive rights to develop and commercialise Cenobamate in Europe from SK Biopharmaceuticals

Innovent treats first cancer patient in Phase I clinical trial of Anti-OX40 Antibody

Mayne Pharma unveils Lexette (halobetasol propionate) foam 0.05% in the US plaque psoriasis market

US FDA posts warning letters to companies illegally selling more than 58 products

Parexel Appoints Former FDA Senior Executives to Global Regulatory Consulting Services

US Patent Issued for AXA Candidate AXA1125

Omeros Names Bumol to Board of Directors

Calliditas Therapeutics announces grant of ODD by US FDA for primary biliary cholangitis

Harmony Biosciences submits Pitolisant NDA with US FDA under priority review

Calliditas Therapeutics wins US FDA orphan drug designation for primary biliary cholangitis

The Janssen Pharmaceutical Companies awarded US FDA approval for DARZALEX (daratumumab) split-dosing revised product label

LASEROPTEK Co passes US FDA 510(k) clearance for PicoLO Picosecond Nd:YAG Laser for dermatology indications and plastic surgery

IDx introduces clinically-aligned autonomous algorithms IDx-DR across healthcare settings in the US for testing diabetic retinopathy

Janssen Pharmaceutical Companies receives US FDA recommendation for SPRAVATO nasal spray CIII to treat treatment-resistant depression