References
- Jazz Pharmaceuticals. Zanidatamab granted priority review for HER2-positive metastatic biliary tract cancer. [Press release.] May 29, 2024. Accessed September 23, 2024. https://investor.jazzpharma.com/news-releases/news-release-details/zanidatamab-granted-priority-review-her2-positive-metastatic
- Ionis Pharmaceuticals, Inc. Ionis announces Olezarsen FCS New Drug Application accepted for Priority Review and enrollment in phase 3 sHTG program completed. [Press release.] June 25, 2024. Accessed September 23, 2024. https://ir.ionis.com/news-releases/news-release-details/ionis-announces-olezarsen-fcs-new-drug-application-accepted
- Lexicon Pharmaceuticals. Lexicon Pharmaceuticals receives December 20, 2024 PDUFA goal date for sotagliflozin type 1 diabetes NDA resubmission. [Press release.] July 16, 2024. Accessed September 23, 2024. https://www.globenewswire.com/en/news-release/2024/07/16/2913701/0/en/Lexicon-Pharmaceuticals-Receives-December-20-2024-PDUFA-Goal-Date-for-Sotagliflozin-Type-1-Diabetes-NDA-Resubmission.html
- Zealand Pharma. Zealand Pharma submits New Drug Application to the US FDA for glepaglutide in short bowel syndrome. [Press release.] December 22, 2023. Accessed September 23, 2024. https://www.globenewswire.com/news-release/2023/12/22/2800463/0/en/Zealand-Pharma-submits-New-Drug-Application-to-the-US-FDA-for-glepaglutide-in-short-bowel-syndrome.html
- Syndax. Syndax announces PDUFA action date extension for revumenib NDA for relapsed or refractory KMT2Ar acute leukemia. [Press release.] July 29, 2024. Accessed September 23, 2024. https://ir.syndax.com/news-releases/news-release-details/syndax-announces-pdufa-action-date-extension-revumenib-nda
- Rhythm Pharmaceuticals announces FDA acceptance for priority review of Supplemental New Drug Application for Imcivree (setmelanotide) in patients as young as 2 years old. [Press release.] August 26, 2024. Accessed October 14, 2024. https://www.globenewswire.com/en/news-release/2024/08/26/2935458/0/en/Rhythm-Pharmaceuticals-Announces-FDA-Acceptance-for-Priority-Review-of-Supplemental-New-Drug-Application-for-IMCIVREE-setmelanotide-in-Patients-as-Young-as-2-years-old.html
- Soleno Therapeutics. Soleno announces US FDA acceptance for filing and Priority Review of NDA for DCCR (diazoxide choline) extended-release tablets in Prader-Willi syndrome. [Press release.] August 27, 2024. Accessed September 23, 2024. https://www.globenewswire.com/en/news-release/2024/08/27/2936152/0/en/Soleno-Therapeutics-Announces-U-S-FDA-Acceptance-for-Filing-and-Priority-Review-of-NDA-for-DCCR-Diazoxide-Choline-Extended-Release-Tablets-in-Prader-Willi-Syndrome.html
- Checkpoint Therapeutics. Checkpoint Therapeutics announces FDA acceptance of BLA resubmission of cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma. [Press release.] July 25, 2024. Accessed September 23, 2024. https://checkpointtx.com/
- Bristol Myers Squibb. FDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). [Press release.] May 6, 2024. Accessed September 23, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx
- Neurocrine Biosciences. Neurocrine Biosciences Announces FDA accepts New Drug Applications and grants priority review for crinecerfont for pediatric and adult patients with CAH. July 1, 2024. Accessed September 23, 2024. [Press release.] https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-us-fda-accepts-new-drug-0