PolarityBio to Present Phase 3 SkinTE Data at SAWC Fall 2026
SALT LAKE CITY — September 29, 2026 PolarityBio announced that results from its pivotal Phase 3 COVER DFUS II...
Priority Review
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Leads Biolabs Gains Japan Orphan Drug Designation for Opamtistomig
NANJING, China — September 28, 2026 Leads Biolabs announced that opamtistomig (LBL-024), its investigational PD-L1/4-1BB bispecific antibody, has received...
Pharming Gains FDA Priority Review for Lower-Dose Joenja
LEIDEN, Netherlands — September 25, 2026 Pharming Group N.V. announced that the U.S. Food and Drug Administration (FDA) has...
AstraZeneca Gains US Priority Review for IMFINZI in MIBC
WILMINGTON, Del. — September 25, 2026 AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted and...
LEO Pharma Gains FDA Priority Review for Dersimelagon
BALLERUP, Denmark — September 18, 2026 LEO Pharma announced that the U.S. Food and Drug Administration (FDA) has accepted...
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PolarityBio Gains FDA Priority Review for SkinTE in DFUs
SALT LAKE CITY, Utah — September 15, 2026 PolarityBio announced that the U.S. Food and Drug Administration (FDA) has...
Bayer Wins FDA Accelerated Approval for Sevabertinib
BERLIN — September 9, 2026 Bayer announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval...
Genentech Gains FDA Priority Review for Enspryng in MOGAD
SOUTH SAN FRANCISCO, Calif. — September 9, 2026 Genentech, a member of the Roche Group, announced that the U.S....
Roche Wins FDA Priority Review for Enspryng in MOGAD
BASEL, Switzerland — September 10, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) granted Priority Review...
Intellia Therapeutics Gains FDA Priority Review for Lonvo-z in HAE
CAMBRIDGE, Mass. — September 8, 2026 Intellia Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted...
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