STAT6d
U.S. health agencies see some chaos — but an FDA approval gets through
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FiercePharma2d
Axsome secures hard-fought FDA nod for rapid-acting migraine drug Symbravo
Meloxicam is a nonsteroidal, anti-inflammatory molecule developed with Axsome’s Molecular Solubility Enhanced Inclusion ...
JD Supra3d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
BioSpace6d
Pfizer Settles Biohaven Kickback Suit for Nearly $60M
Biohaven wielded meals at high-end restaurants and paid speaking opportunities to induce healthcare providers to prescribe ...
The Pharma Letter6d
Positive Phase III results for Pfizer’s Braftovi combo
US pharma giant Pfizer on Saturday announced positive results from the Phase III BREAKWATER trial evaluating its Braftovi ...
appliedclinicaltrialsonline5d
Pfizer Shares Positive Data from Phase III BREAKWATER Trial of Braftovi Combination Following Accelerated Approval
Being evaluated for the treatment of metastatic colorectal cancer, the combination regimen achieved an objective response ...
dermatologyadvisor2d
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
A long-awaited alternative to opioids is on the FDA doorstep. Can Vertex seal the deal?
Vertex Pharmaceuticals’ non-opioid pain medication is up for FDA approval this week. Other drugmakers have found safer ...
PMLiVE6d
Pfizer shares positive late-stage results for Braftovi regimen in colorectal cancer
Pfizer has shared positive results from a late-stage study of its Braftovi (encorafenib) combination in BRAF V600E-mutant ...
Novo Nordisk's Ozempic gets FDA approval for kidney disease
Novo Nordisk (NVO) said its popular diabetes drug Ozempic, also known as semaglutide, has been approved to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular ...