News

City limits: Application rejection letters issued for Omaha's general election
The Douglas County Election Commissioner’s Office issued more than 150 "application rejection letters" for the general ...
ImmunityBio Slides Following FDA Refusal-to-File Letter
Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for ...
PharmExec4d
FDA Issues Refusal to File for ImmunityBio’s sBLA for Anktiva in BCG-Unresponsive NMIBC
The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application ...
ImmunityBio Slapped With FDA Refusal To File Letter For Expanded Use Of Its Bladder Cancer Drug
ImmunityBio's ANKTIVA sBLA for papillary bladder cancer was rejected by the FDA despite prior support, prompting the company ...
ImmunityBio: Getting Whiplash After FDA's Refusal To File For Anktiva's sBLA
ImmunityBio's sBLA for Anktiva was unexpectedly rejected by the FDA, contradicting prior positive feedback and approval for a ...
The South African on MSN3d
Julius Malema’s UK visa rejection letter LEAKED
EFF leader Julius Malema has been denied a visa to travel to the United Kingdom, prompting accusations of political silencing ...
Targeted Oncology5d
FDA Issues Refusal to File for Nogapendekin Alfa Plus BCG in Papillary NMIBC
The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior ...
Tax Guru2d
CESTAT Remits Unreasoned Rejection of Interest Waiver for Power Project
CESTAT remits power project interest waiver case back to Chief Commissioner, citing unreasoned rejection and violation of ...