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EUA Granted to BioSynchronicity for Covid test

[ Price : $8.95]

Federal Register notice: FDA announces that an emergency use authorization was granted 3/24 to BioSynchronicity Corp. for its C-Sy...

Prostate Cancer Drug Gets Fast Track

[ Price : $8.95]

FDA grants Lantheus Holdings and Point Biopharma Global a fast track designation for 177Lu-PNT2002 for treating metastatic castrat...

Medtronics MiniMed 780G Gets FDA Approval

[ Price : $8.95]

After a delay caused by an FDA 2021 inspection and Warning Letter, the agency approves Medtronics MiniMed 780G insulin pump.

bluebird bio BLA for Sickle Cell Gene Therapy

[ Price : $8.95]

bluebird bio files for priority review a BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for patients with sickle ce...

Generic Group Questions Guide on Guidance Meetings

[ Price : $8.95]

Generic drug lobbying arm says FDAs draft guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applican...

Foghorn Therapeutics Hit with Partial Clinical Hold

[ Price : $8.95]

FDA places a partial clinical hold on a Foghorn Therapeutics clinical study of FHD-609 in synovial sarcoma and SMARCB1-deleted tum...

FDA Clear Maxtecs Oxygen Monitor

[ Price : $8.95]

FDA clears a Maxtec 510(k) for the MaxO2 ME+p, an oxygen monitor with integrated pressure monitoring intended for continuous patie...

Avanos Medical Recalls Respiratory Suction Device

[ Price : $8.95]

Avanos Medical recalls its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold after receiving complaint...

FDA Extends Review of Daiichi Leukemia NDA

[ Price : $8.95]

FDA extends by three months its review of a Daiichi Sankyo NDA resubmisson for quizartinib in combination with chemotherapy for tr...

CDER Denies Bausch Petition on Duobrii ANDAs

[ Price : $8.95]

CDER denies a 2021 citizen petition from Bausch Health that urged FDA not to approve any ANDA that cites Duobrii as the reference-...