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Home » Topics » Regulatory

Regulatory
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Cancer

Onkure's PI3Kα H1047R inhibitor OKI-219 cleared to enter clinic for solid tumors

Jan. 5, 2024
Onkure Inc. has received FDA clearance of its IND application for OKI-219, a mutant selective PI3Kα H1047R inhibitor, for solid tumors.
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Cancer

Quanta advances KRAS inhibitor pipeline with IND, candidate selection

Jan. 5, 2024
Quanta Therapeutics Inc. has announced progression of its pipeline of KRAS-directed drug candidates, with the receipt of IND approval from the FDA for QTX-3034.
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Magnifying glass, FDA concept image

US FDA looks to streamline its guidance practices

Jan. 4, 2024
By Mari Serebrov
Are there other guidances the U.S. FDA should release as final without going through the draft and public comment process first? That’s one of the questions the FDA wants stakeholders to comment on as it updates its best practices for guidance.
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Handling of scientific dissent at US FDA under the microscope

Jan. 4, 2024
By Mari Serebrov
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
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’23 in review

FDA’s guidance for CDS sets new bar for controversy

Jan. 4, 2024
By Mark McCarty

The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.


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Regulatory actions for Jan. 4, 2024

Jan. 4, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocomposites, Ingelheim, Immunexoress, Irhythm, Kuros, Mentice, Renovos, Simbiosys.
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Renovos Renovite gel and reliable fusion

Renovos wins breakthrough device designation for nanoclay gel

Jan. 4, 2024
By Shani Alexander
Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.
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Digital brain and silhouette

FDA designates digital therapy for schizophrenia a breakthrough device

Jan. 4, 2024
By Annette Boyle
The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
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Hand holding injection pen

No injunction yet for state’s epinephrine affordability program

Jan. 3, 2024
By Mari Serebrov
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts.
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Regulatory actions for Jan. 3, 2024

Jan. 3, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robotica, Sofwave.
Read More
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