Regulatory
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.
The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.
In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.
The U.K.’s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.
After a Phase III trial did not meet its primary endpoint, Bayer will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market following discussions with the FDA.
In today’s challenging environment, here are some creative ways biotechs have found to survive and thrive.
Over the next two weeks, the FDA is set to decide on New Drug Applications from Pacira, CorMedix and Aldeyra and hold an advisory committee meeting for two overdue confirmatory trials from Acrotech.
The Federal Trade Commission is challenging over 100 pharmaceutical patents held by prominent drugmakers, including AbbVie, AstraZeneca and Boehringer Ingelheim, for their listings.
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