The FDA on 1 April unveiled its final guidance advising makers of brand-name opioids about what they need to do to obtain abuse-deterrent language in the labeling of their products.
The FDA on 1 April unveiled its final guidance advising makers of brand-name opioids about what they need to do to obtain abuse-deterrent language in the labeling of their products.
The document, Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling, describes the FDA's expectations about what types of studies should be conducted to demonstrate that a given formulation has...
All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.
But the French major is still keen on early-stage M&A.
Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.
Deal snapshot: With several internal non-opioid pain candidates in Phase II or earlier, Lilly looks to add R&D potential in pain with $1bn buyout of SiteOne.
The company highlighted the KLK2-targeting agent’s safety at ASCO but it may have to rely on combinations to make pasritamig competitive.
The drugmaker presented oral abstracts at the meeting for Libtayo in adjuvant cutaneous squamous-cell carcinoma and linvoseltamab in multiple myeloma.
ASCO sees the debut of Lupin’s PRMT5 inhibitor candidate LRNP7457, currently in Phase I studies in India. While no drug with this mechanism of action has been approved anywhere so far, several candidates are in clinical trials.
