A drug that looked like it could do no wrong in the FDA's eyes, Bristol-Myers Squibb Co.'s Opdivo (nivolumab), actually got a rejection from the agency to expand the medicine's use as a single agent for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
A drug that looked like it could do no wrong in the FDA's eyes, Bristol-Myers Squibb Co.'s Opdivo (nivolumab), actually got a rejection from the agency to expand the medicine's use as a single agent for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
But the FDA last week also awarded the medicine its sixth indication in less than 12 months as a single...
An updated abstract from the World Conference on Lung Cancer has given analysts confidence in BioNTech’s VEGF-A/PD-L1 bispecific challenger
Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.
The drug is one of multiple candidates in the class that have been pulled from development, though it is not the company’s lead candidate.
Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.
All eyes on chronic urticaria after eosinophilic esophagitis disappointment.
An updated abstract from the World Conference on Lung Cancer has given analysts confidence in BioNTech’s VEGF-A/PD-L1 bispecific challenger
The total value of deals for GLP-1-associated assets so far this year is already double that of the previous two years combined, with China-originated molecules accounting for a substantial majority. Scrip takes a look at some of the key factors behind this activity.
