FDA draft guidance aims to accelerate the development of personalized therapies for rare diseases, impacting over 7,000 conditions.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Roche FDA decision on Giredestrant expected by December 2023, potentially setting a new standard for breast cancer treatment.
BMS FDA Review: The FDA has accepted BMS’s protein degrader for review, potentially impacting the US market with new treatment options.
Moderna FDA review progresses for mRNA flu vaccine after a Type A meeting, impacting the US market.
COMP360 psilocybin FDA application progresses with Phase 3 data, aiming to be the first classic psychedelic approved in the U.S.
FDA removes box warning from six hormone replacement therapies, impacting millions of menopausal women in the US.
Moderna mRNA flu vaccine faces a setback as the FDA refuses to review its application, citing inconsistencies with prior communications.
Regenxbio FDA rejection impacts its gene therapy for Hunter Syndrome, marking a significant regulatory setback.
Amgen inflammatory drug faces regulatory scrutiny as the company refuses FDA’s withdrawal request, impacting its market strategy.
Tenpoint FDA approval marks a significant step for its presbyopia eye drop, supported by $235 million in funding.