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FDA Grants Priority Review to Takeda Narcolepsy Drug

Feb 11, 2026
Takeda has taken a major step toward introducing a novel treatment for narcolepsy type 1 after the U.S. Food and Drug Administration accepted its New Drug Application and granted…
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FDA Rejects REGENXBIO Gene Therapy for Hunter Syndrome

Feb 11, 2026
REGENXBIO Inc. has received a setback in its efforts to bring a gene therapy to patients with Hunter syndrome, after the U.S. Food and Drug Administration (FDA) issued a Complete…
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Biocodex, THX Pharma Partner on Rare Disease Therapies

Feb 11, 2026
Biocodex and THX Pharma (Theranexus) have entered a strategic licensing agreement aimed at advancing treatments for three rare and serious genetic disorders, marking a significant…
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Measuring Impact in Medical Affairs Summit: Redefining How Medical Affairs Can Demonstrate its…

Feb 11, 2026
As Medical Affairs continues to evolve into a strategic cornerstone of the biopharma industry, the ability to clearly define, measure, and communicate impact has never been more…
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Everest Medicines Licenses Novel Kidney Disease Drug MT1013

Feb 6, 2026
Everest Medicines has entered an exclusive licensing agreement with Shaanxi Micot Pharmaceutical Technology to commercialize the experimental therapy MT1013 across China and the…
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Eisai, Henlius Partner to Bring Serplulimab to Japan

Feb 6, 2026
Eisai Co., Ltd. and Shanghai Henlius Biotech have signed an exclusive commercialization and co-exclusive development and manufacturing licensing agreement for the anti-PD-1 antibody…
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Grünenthal, Apotex Sign Deal for Nebido Canada Rights

Feb 6, 2026
Grünenthal and Apotex Inc. have announced a new licensing agreement granting Apotex exclusive rights in Canada to Nebido (testosterone undecanoate), a long-acting injectable therapy…
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PrimeGen US Plans Nasdaq Listing via $1.5B SPAC Deal

Feb 5, 2026
PrimeGen US, a biotechnology company focused on regenerative medicine, has agreed to merge with special purpose acquisition company DT Cloud Star Acquisition Corporation in a…
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CEPI, Samsung Biologics Partner for Rapid Pandemic Vaccine Production

Feb 4, 2026
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with contract development and manufacturing organization Samsung Biologics to strengthen global readiness for…
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FDA Grants Breakthrough Status to Relay Breast Cancer Therapy

Feb 4, 2026
Relay Therapeutics has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its investigational drug zovegalisib in combination with fulvestrant for…
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Press Releases

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