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  • TABLET;ORAL - 0.5MG
  • TABLET;ORAL - 1MG
  • TABLET;ORAL - 2MG
  • TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.prnewswire.com/news-releases/aadi-bioscience-to-present-new-non-clinical-data-highlighting-combinability-of-nab-sirolimus-at-the-american-association-for-cancer-research-aacr-annual-meeting-302111705.html

PR NEWSWIRE
09 Apr 2024

https://www.indianpharmapost.com/drug-approval/concept-medical-receives-usfda-approval-for-sirolimus-drug-coated-balloon-15466

INDIANPHARMAPOST
01 Apr 2024

https://www.prnewswire.com/news-releases/aadi-bioscience-presents-new-subgroup-analysis-of-patients-with-advanced-malignant-pecoma-of-gynecologic-origin-treated-with-nab-sirolimus-at-society-of-gynecologic-oncology-sgo-302090852.html

PR NEWSWIRE
17 Mar 2024

https://www.globenewswire.com/news-release/2023/07/20/2708226/0/en/Palvella-Therapeutics-Announces-Planned-Pivotal-Phase-3-Study-Design-of-QTORIN-3-9-Rapamycin-Anhydrous-Gel-QTORIN-rapamycin-for-the-Treatment-of-Microcystic-Lymphatic-Malformations.html

GLOBENEWSWIRE
20 Jul 2023

https://www.ema.europa.eu/en/documents/overview/hyftor-epar-medicine-overview_en.pdf

EMA
08 Jun 2023

https://www.prnewswire.com/news-releases/rare-disease-treatment-hyftor-sirolimus-topical-gel-0-2-coverage-expanded-by-medicaid-including-in-key-us-states-301770178.html

PR NEWSWIRE
14 Mar 2023

https://www.globenewswire.com/news-release/2023/03/09/2623986/0/en/Palvella-Therapeutics-Announces-Positive-Topline-Results-from-Phase-2-Study-of-QTORIN-3-9-Rapamycin-Anhydrous-Gel-QTORIN-rapamycin-for-the-Treatment-of-Microcystic-Lymphatic-Malfor.html

GLOBENEWSWIRE
09 Mar 2023

https://www.globenewswire.com/news-release/2023/02/21/2611988/0/en/Palvella-Therapeutics-Announces-Pipeline-Update-on-QTORIN-3-9-Rapamycin-Anhydrous-Gel-QTORIN-Rapamycin-for-Serious-Rare-Genetic-Skin-Diseases-with-No-FDA-approved-Therapies.html

GLOBENEWSWIRE
21 Feb 2023

https://www.prnewswire.com/news-releases/sirolimus-coated-balloon-in-btk-treatment-makes-a-bold-presence-at-veith-2022--lights-up-ny-times-square-nasdaq-301692476.html

PRNEWSWIRE
02 Dec 2022

https://www.prnewswire.com/news-releases/mirati-therapeutics-and-aadi-bioscience-partner-to-evaluate-the-combination-of-adagrasib-with-nab-sirolimus-in-patients-with-advanced-non-small-cell-lung-cancer-and-other-solid-tumors-with-a-krasg12c-mutation-301646795.html

PRNEWSWIRE
12 Oct 2022

https://www.prnewswire.com/news-releases/hyftor-sirolimus-topical-gel-0-2-the-first-fda-approved-topical-treatment-for-facial-angiofibroma-associated-with-tuberous-sclerosis-is-now-available-in-the-us-301614013.html

PRNEWSWIRE
30 Aug 2022

https://www.prnewswire.com/news-releases/hyftor-sirolimus-topical-gel-0-2-available-through-alliancerx-walgreens-pharmacy-301613256.html

PRNEWSWIRE
29 Aug 2022

https://www.prnewswire.com/news-releases/nobelpharma-america-presents-findings-from-natural-history-database-of-the-tsc-alliance-on-the-characterization-of-facial-angiofibroma-and-the-use-of-topical-rapamycin-in-people-with-tuberous-sclerosis-complex-in-the-us-at-the-30t-301601652.html

PRNEWSWIRE
09 Aug 2022

https://www.prnewswire.com/news-releases/nobelpharma-america-debuts-new-product-hyftor-sirolimus-topical-gel-0-2-at-the-2022-world-tsc-conference-301591913.html

PRNEWSWIRE
25 Jul 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-25-2022-1653460687.pdf

FDA
25 May 2022

https://www.fiercepharma.com/pharma/first-fda-approves-topical-sirolimus-rare-disease-lesions

N.P. Taylor FIERCEPHARMA
06 Apr 2022

https://www.prnewswire.com/news-releases/fda-approves-nobelpharmas-hyftor-sirolimus-topical-gel-0-2-301516272.html

PRNEWSWIRE
04 Apr 2022

https://www.globenewswire.com/news-release/2022/03/31/2414284/0/en/Aadi-Bioscience-Announces-First-Patient-Dosed-in-its-PRECISION-1-Phase-2-Registrational-Trial-of-nab-Sirolimus-in-Patients-with-Solid-Tumors-Harboring-Pathogenic-Inactivating-Alter.html

GLOBENEWSWIRE
31 Mar 2022

https://www.businesswire.com/news/home/20220202005093/en

BUSINESSWIRE
02 Feb 2022

https://finance.yahoo.com/news/aadi-bioscience-announces-fda-approval-110000788.html

YAHOOFINANCE
24 Nov 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-29-2021-1632907538.pdf

FDA
29 Sep 2021

https://www.newswise.com/articles/organ-rejection-drug-rapamycin-may-improve-cellular-health-function-in-myopathy-patients?sc=rsrn

NEWSWISE
14 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214753

FDA
17 Mar 2021

https://www.expresspharma.in/drug-approvals/glenmark-pharma-receives-usfda-approval-for-sirolimus-tablets/

EXPRESS PHARMA
19 Oct 2020

https://www.globenewswire.com/news-release/2020/07/01/2056190/0/en/Timber-Pharmaceuticals-Announces-All-CONTROL-Study-Sites-Open-and-Enrolling-Patients-with-Moderate-to-Severe-Congenital-Ichthyosis.html

GLOBENEWSWIRE
01 Jul 2020

https://www.globenewswire.com/news-release/2020/04/03/2011436/0/en/resTORbio-Announces-Delay-of-its-Ongoing-Phase-1b-2a-trial-of-RTB101-in-Patients-with-Parkinson-s-Disease-Due-to-COVID-19-Level-4-Alert-in-New-Zealand.html

GLOBENEWSWIRE
03 Apr 2020

https://www.globenewswire.com/news-release/2019/11/13/1946332/0/en/Palvella-Therapeutics-Commences-Phase-3-Portion-of-Phase-2-3-Pivotal-Study-of-PTX-022-in-Pachyonychia-Congenita.html

GLOBENEWSWIRE
13 Nov 2019

https://seekingalpha.com/news/3510684-surmodics-sundance-catheter-breakthrough-device-u-s

Douglas W. House SEEKINGALPHA
29 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211406

FDA
25 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211212

FDA
19 Oct 2019

https://www.fiercebiotech.com/medtech/concept-medical-racks-up-breakthrough-designations-for-its-drug-coated-balloons-now-for

Conor Hale FIERCE BIOTECH
30 Aug 2019

https://www.contractpharma.com/contents/view_breaking-news/2019-08-27/orchestra-biomed-appoints-chief-medical-officer/

CONTRACT PHARMA
27 Aug 2019

https://www.prnewswire.com/news-releases/vascular-therapies-completes-enrollment-in-the-access-study-a-us-phase-iii-clinical-trial-300903622.html

PR NEWSWIRE
19 Aug 2019

https://www.fiercebiotech.com/medtech/terumo-plans-to-take-orchestra-biomed-s-sirolimus-balloon-international-35m-deal

Conor Hale FIERCE BIOTECH
14 Jun 2019

https://www.thepharmaletter.com/in-brief/brief-medpharm-and-palvella-expand-pachyonychia-congenita-partnership

THEPHARMALETTER
19 Feb 2019

https://www.businesswire.com/news/home/20190103005021/en

BUSINESSWIRE
03 Jan 2019

https://www.fiercebiotech.com/research/new-insight-into-why-malaria-drugs-work-against-some-cancers-could-boost-drug-development

Arlene Weintraub FIERCE BIOTECH
16 Nov 2018

https://www.fiercebiotech.com/biotech/bayer-s-americas-pharma-head-takes-ceo-job-at-selecta-biosciences?mkt_tok=eyJpIjoiTkdFME16TTJZVGd6WXpJMSIsInQiOiJTZzFodmp2OFR2bzFqMnJxcVM0UlczR1kzc204aDk5eWdvOVk2TFNWOVNYaDF5T1BoSEFJK0kwdXlEWTA1a0VIUG9RdjRjUGpPa2owNWxnWGt1WFwvRVhKdkNOUnNKNTdJUWhhWHFvSGZxQnIyNkJpQ1pReWVEdVJ5RUdZXC9KdU1nIn0%3D&mrkid=67302085

Conor Hale FIERCE BIOTECH
27 Sep 2018

https://www.prnewswire.com/news-releases/micell-technologies-announces-expanded-patent-estate-300616684.html

PRNEWSWIRE
20 Mar 2018

http://www.xconomy.com/texas/2017/08/07/new-rapamycin-ceo-hired-to-handle-funding-fda-inflection-points/

David Holley XCONOMY
07 Aug 2017

http://www.pharmatimes.com/news/kymabs_antibody_shows_early_promise_in_gvhd_prophylaxis_1180188

Selina McKee PHARMATIMES
06 Dec 2016

http://www.fiercebiotech.com/biotech/mixed-late-stage-data-for-santen-eye-drug-but-still-plots-fda-submission

Ben Adams FIERCE BIOTECH
28 Nov 2016

http://nanotechweb.org/cws/article/tech/65778

Belle Dumé NANO TECH WEB
04 Aug 2016

https://globenewswire.com/news-release/2016/07/19/857046/0/en/Selecta-Biosciences-Announces-Gene-Therapy-Programs-for-Two-Rare-Genetic-Metabolic-Disorders.html

GLOBENEWSWIRE
19 Jul 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-recalls-9330-bottles-of-sirolimus-tablets-in-us/articleshow/53193097.cms

ECONOMIC TIMES
14 Jul 2016

http://www.prnewswire.com/news-releases/novartis-drug-afinitor-significantly-reduces-seizures-in-phase-iii-study-of-patients-with-tuberous-sclerosis-complex-300254627.html

PR NEWS WIRE
21 Apr 2016

http://www.prnewswire.com/news-releases/neue-praklinische-daten-zeigen-eine-groWere-antitumorale-wirkung-beim-nierenzellkarzinom-durch-kombination-von-lenvatinib-mit-everolimus-im-vergleich-zu-einem-der-beiden-wirkstoffe-allein-576162331.html

PR NEWSWIRE
18 Apr 2016

http://www.reuters.com/article/us-pfizer-settlement-idUSKCN0VP1G5

Amrutha Penumudi REUTERS
17 Feb 2016

http://www.business-standard.com/article/opinion/large-pharma-companies-to-see-muted-growth-in-fy16-115082800781_1.html

Malini Bhupta BUSINESS STANDARD
28 Aug 2015

http://pipeline.corante.com/archives/2015/06/18/aging_as_a_disease.php

Derek CORANTE
18 Jun 2015
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