Enforcement Report - Week of November 29, 2023
NAYZILAM Results Published in 'Epilepsy & Behavior'
Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. Now, North Carolina-based specialty drugmaker Exela Pharma Sciences has taken the contamination hit.
Enforcement Report - Week of June 7, 2023
BRUSSELS and DÜSSELDORF, Germany, Jan. 24, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces the establishment of Neuraxpharm Belgium to cover Belgium and Luxembourg, completing its presence in Benelux as it continues its expansion pathway in Europe.
NASHVILLE, Tenn.--(BUSINESS WIRE)--Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced top-line results of its Phase 2 pivotal efficacy and safety study for its lead product candidate, MELT-300, a sublingual, needle- and opioid-free patented formulation for procedural sedation during cataract surgery. Based on the outcome of the MELT-300 data, the company intends to request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of this study and the continued clinical development of MELT-300.
Cipla's Generic Midazolam Receives Approval in the U.S.
CROSSJECT (ISIN: FR0011716265; Ticker: ALCJ), a specialty pharma company that is developing and will soon be marketing a portfolio of drug / device combinations for use in emergency situations, is announcing an agreement with BARDA on ZENEO® Midazolam.
Enforcement Report - Week of January 5, 2022