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BioWorld - Friday, June 26, 2026
Home » Topics » Regulatory

Regulatory
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2019 Medical Innovation Summit

Experts tackle the current state of patentability

Oct. 25, 2019
By Liz Hollis
CLEVELAND – Patents took center stage on the final morning of Cleveland Clinic's Medical Innovation Summit, with two experts shedding some light on the issues surrounding patentability – particularly in light of recent legal cases and a hearing before a subcommittee of the Senate Judiciary Committee.
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Regulatory front Oct. 24, 2019

Oct. 24, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front

Oct. 24, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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FDA breast implant draft urges biennial MRI or ultrasound

Oct. 24, 2019
By Mark McCarty
The U.S. FDA's draft guidance for labeling and patient information for breast implants addresses concerns over anaplastic large cell lymphoma, but the draft also recommends biennial examination via ultrasound or MRI after five years, a recommendation that could prove a boon to makers of these imaging systems.
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Regulatory front Oct. 23, 2019

Oct. 23, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front

Oct. 23, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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I-Mab scores second China IND with its CD38 antibody

Oct. 23, 2019
By David Ho
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
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FDA approves Trikafta for cystic fibrosis

Oct. 22, 2019

Regulatory front Oct. 22, 2019

Oct. 22, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Assertio stock continues downward slide after CRL

Oct. 22, 2019
By Lee Landenberger
The complete response letter (CRL) received by Assertio Therapeutics Inc.'s development partner, West Therapeutic Development LLC, regarding its NDA for cosyntropin (synthetic adrenocorticotropic hormone, ACTH) knocked Assertio's stock back 28% on Monday.
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