You are here: Industry Insights > FDA

News List

DURECT Announces Outcome of POSIMIR FDA Advisory Committee Meeting americanpharmaceuticalreview
January 19, 2020
DURECT announced the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met to discuss the Class 2 New Drug Application (NDA) resubmission for POSIMIR® (bupivacaine extended-release solution).
Novo Nordisk secures FDA expanded indication for Ozempic pharmaceutical-technology
January 19, 2020
The US Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Ozempic (semaglutide). The once-weekly injection is now indicated to reduce the risk of major adverse cardiovascular events (MACE) ...
Lannett Announces FDA Approval of NDA for Branded Anesthetic Product americanpharmaceuticalreview
January 17, 2020
Lannett Company announced the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL) ...
FDA Grants Fast Track Designation for Heart Failure Treatment americanpharmaceuticalreview
January 17, 2020
Arena Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation for APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of decompensated heart failure (DHF).
FDA issues warning letter to Health Pharma for cGMP violations europeanpharmaceuticalreview
January 17, 2020
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
BMS secures FDA priority review for NSCLC treatment combination pharmaceutical-technology
January 17, 2020
Bristol-Myers Squibb Company (BMS) has secured the US Food and Drug Administration (FDA) priority review for a drug combination to treat metastatic or recurrent non-small cell lung cancer (NSCLC).
FDA grants Clovis’ Rubraca fast track designation for prostate cancer pharmaceutical-technology
January 17, 2020
Colorado-based Clovis Oncology has received fast track designation from the US Food and Drug Administration (FDA) for Rubraca (rucaparib) as a monotherapy for BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC) adult patients.
Weight Control Drug Lorcaserin May Raise Cancer Risk drugs
January 16, 2020
The prescription weight control medicine lorcaserin (Belviq, Belviq XR) may increase the risk for cancer, according to the results of a clinical trial assessing the safety of the drug, the U.S. Food and Drug Administration says.
FDA issues alert for cancer risk from Belviq (lorcaserin) europeanpharmaceuticalreview
January 16, 2020
The US FDA has announced a warning to healthcare professionals and patients that the weight management drug Belviq may be a cause of cancer.
Presage Receives FDA Clearance of First IND Application for CIVO Technology americanpharmaceuticalreview
January 15, 2020
Presage Biosciences announced the U.S. Food and Drug Administration (FDA) has approved its first Exploratory Investigational New Drug (IND) application for a Phase 0 study utilizing its CIVO platform.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page