Regulatory
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.
In an overwhelming vote of support, the U.S. House of Representatives approved the creation of a new department within the National Institutes of Health that is focused on biomedical innovation.
The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.
Krystal Biotech announced that it submitted a Biologics License Application to the FDA for its candidate B-VEC, intended for the treatment of dystrophic epidermolysis bullosa.
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
For years, PTC Therapeutics has attempted to win regulatory approval for its DMD drug, Translarna. Now, the company believes it has data that will support another filing for FDA approval.
An FDA advisory committee voted against Acadia Pharmaceutical’s supplemental New Drug Application of Nuplazid tablets for the treatment of Alzheimer’s-related psychosis.
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