FDA grants priority review for potential bronchiectasis treatment
BRIDGEWATER, N.J. - Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company with a market capitalization of $14.57 ...
Targeted Oncology14h
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Insmed Gets Speedy FDA Review of Brensocatib for Bronchiectasis
The Bridgewater, N.J., biopharmaceutical company said brensocatib has the potential to become the first and only approved treatment for non-cystic fibrosis bronchiectasis, which causes the lungs' ...
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will ...
JD Supra3d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Rolling Out8d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
FDA pauses updates on foodborne outbreak probes as health agencies regroup on communications
The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food ...
FDA approves pig organ transplant trials for patients with kidney failure
The first clinical trials using organs from genetically modified pigs offer hope to patients with kidney failure, who face a ...
infectiousdiseaseadvisor.com3d
Prefilled Syringe Presentation of Shingrix Under FDA Review
The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
thecardiologyadvisor.com3d
Nasal Spray Formulation of Bumetanide Under FDA Review
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
dvm3602d
Drug label is updated for pain management therapy
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
Monthly Prescribing Reference11d
Nasal Spray Formulation of Bumetanide Under FDA Review
A Prescription Drug User Fee Act target date of September 14, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application ...