Tag: FDA
FDA Directors Peter Marks and Jeffrey Shuren to Speak on COVID-19...
Rockville, MD, USA, June 22, 2021 (GLOBE NEWSWIRE) -- The Regulatory Affairs Professionals Society (RAPS) today announced that two of the...
MannKind and United Therapeutics Achieve a Major Milestone in the Development...
Tyvaso DPI includes the second compound formulated with MannKind’s Technosphere® technology to be reviewed by the FDAFDA review expected to be complete in...
“The END of the CDC, NIH, FDA?” wonders Dr Harte
United States, California, Corte Madera, June 07, 2021 (GLOBE NEWSWIRE) -- Dr. Don Harte, noted chiropractic activist, 40-year chiropractic veteran, and...
Paratek Pharmaceuticals Announces FDA Approval of NUZYRA® (omadacycline) Oral Only Dosing...
- Oral-only dosing for the Treatment of CABP Expands the Commercial Opportunity for Primary Care Promotion - Primary Care Market Opportunity for...
BridgeBio Pharma’s Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA...
Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma...
Ocugen On Track to Submit Emergency Use Authorization Application to U.S....
Active discussions with FDA related to COVAXIN initiated late last yearMaster file submitted to FDA on March 26, 2021; awaiting feedback from FDA...
Larimar Therapeutics Reports FDA Clinical Hold on CTI-1601 and Termination of...
BALA CYNWYD, Pa., May 25, 2021 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on...
Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™...
EMPAVELI, the first targeted C3 therapy, is approved for use in adults with PNH who are:Treatment naïveSwitching from C5 inhibitor Soliris® (eculizumab) Switching...
FMW Media’s “New To The Street” Syndicated TV Show Features AzurRx...
NEW YORK, May 14, 2021 (GLOBE NEWSWIRE) -- FMW Media Corp. announces that its “New To The Street” business TV show...