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Enforcement Report - Week of October 23, 2024
23 Oct 2024 //
FDA
Naprod Life Supports Cisplatin Oncology Treatment In Germany
05 Oct 2024 //
PRESS RELEASE
Cisplatin Europe Offers EUGMP Approved Cancer Drug Mfg Facilities
27 Jul 2024 //
PRESS RELEASE
FDA commissioner heralds end to US shortfall of chemo drug cisplatin
01 Jul 2024 //
FIERCE PHARMA
FDA Approves Opdivo for First-Line Treatment of Urothelial Carcinoma
07 Mar 2024 //
BUSINESSWIRE
FDA Issues Reminder of Non-Substitution of PEDMARK for Pediatric Patients
01 Feb 2024 //
GLOBENEWSWIRE
Sensorion Provides an Update on NOTOXIS
18 Dec 2023 //
BUSINESSWIRE
FDA Accepts for Priority Review BMS’ Application for Opdivo for Urothelial Carcinoma
05 Dec 2023 //
BUSINESSWIRE
Accord Healthcare restarts production of cancer drug cisplatin
16 Nov 2023 //
FIERCE PHARMA
Merck Receives Positive EU CHMP Opinion for KEYTRUDA for Biliary Tract Cancer
10 Nov 2023 //
BUSINESSWIRE
FDA Approves Merck’s KEYTRUDA & Cisplatin as Treatment for Biliary Tract Cancer
01 Nov 2023 //
BUSINESSWIRE
EMA Validates Application for Opdivo for First-Line Treatment of Urothelial Carcinoma
30 Oct 2023 //
PRESS RELEASE
Petrylak Provides Perspective on the Nationwide Cisplatin/Carboplatin Shortage
28 Aug 2023 //
ONCLIVE
Cisplatin, carboplatin shortages raise questions about impact on trials
18 Aug 2023 //
ENDPTS
FDA allows more imports of key cancer med from China`s Qilu
13 Jul 2023 //
FIERCE PHARMA
FDA to import more of cancer drug from China
12 Jul 2023 //
ENDPTS
FDA inspection at India pharma at center of the cisplatin shortage cites quality issues
30 Jun 2023 //
ENDPTS
FDA to allow temporary overseas production of chemo drugs
06 Jun 2023 //
FIERCE PHARMA
Abstract Evaluating Allarity`s DRP Companion Diagnostic for Cisplatin Accepted
11 Apr 2023 //
GLOBENEWSWIRE
Nanopharmaceutics Announces the End of Patient Recruitment for PIII Study
02 Nov 2022 //
PRNEWSWIRE
Sensorion Announces Approval to Initiate Phase 2a Trial of SENS-401
24 Oct 2022 //
BUSINESSWIRE
U.S. FDA approves Fennec`s hearing loss therapy
22 Sep 2022 //
REUTERS
Merck`s KEYTRUDA & Chemotherapy Showed Sustained Survival Benefit
11 Sep 2022 //
BUSINESSWIRE
HERTHENA-Lung02 PIII Trial of Patritumab Deruxtecan Initiated in Patients
08 Aug 2022 //
BUSINESS WIRE
Innovent and Lilly Jointly Announce the Approval of TYVYT by China NMPA
20 Jun 2022 //
PRNEWSWIRE
Junshi Nabs NMPA Approval of sNDA for Toripalimab plus Paclitaxel and Cisplatin
16 May 2022 //
GLOBENEWSWIRE
Seagen and Astellas Announce Initial Results of PADCEV in MIBC
14 Feb 2022 //
BUSINESSWIRE
Sensorion to Present Three Posters on SENS-401 in Cisplatin Ototoxicity Models
02 Feb 2022 //
BUSINESSWIRE
Rafael Completes Enrollment in Phase 2 Trial of CPI-613 in biliary tract cancer
18 Jan 2022 //
GLOBENEWSWIRE
Innovent Releases ORIENT-31 Phase 3 Study Results in EGFR-mutated NSCLC
20 Nov 2021 //
PRNEWSWIRE
Coherus and Junshi Biosciences Announce FDA Acceptance of BLA Filing
01 Nov 2021 //
GLOBENEWSWIRE
IMFINZI+chemotherapy tripled patient OS at 3 years in PIII trial in ES-SCLC
18 Sep 2021 //
BUSINESSWIRE
Zanidatamab PII Trial Shows Promising Data in First-Line HER2-Positive GEA
16 Sep 2021 //
BUSINESSWIRE
Rafael Pharmaceuticals Initiates PII for CPI-613+Gemcitabine+Cisplatin in BTC
25 Aug 2021 //
GLOBENEWSWIRE
Merck to discontinue PII study of bintrafusp alfa+gemcitabine+cisplatin for BTC
25 Aug 2021 //
PHARMABIZ
Fennec Announces FDA Acceptance of New Drug Application Resubmission for PEDMARK
22 Jun 2021 //
GLOBENEWSWIRE
Atezolizumab Delays Disease Recurrence in Patients With Early-Stage Lung Cancer
07 Jun 2021 //
FIRSTWORLDPHARMA
Final Data from the Phase Ib Study of Acelarin plus Cisplatin in Patients
01 Dec 2020 //
GLOBENEWSWIRE
Galera Therapeutics to Host Virtual KOL Event on Cisplatin-Induced ckd
18 May 2020 //
GLOBENEWSWIRE
NuCana Announces Re-Opening of Global Phase III Study of Acelarin Plus Cisplatin
05 May 2020 //
GLOBENEWSWIRE
Fennec Announces Proposed Public Offering of Common Shares
29 Apr 2020 //
GLOBENEWSWIRE
NANOBIOTIX Provides Updates on Clinical Development Continuity in the Context
21 Apr 2020 //
CONTRACT PHARMA
EMA issues positive opinion for NuCana`s acelarin in combo with cisplatin
06 Mar 2020 //
PHARMABIZ
Akcea & Ionis report positive topline ph 2 study results of AKCEA-ANGPTL3-LRx
28 Jan 2020 //
GLOBENEWSWIRE
Otonomy Presents Preclinical Results for GJB2 Gene Therapy Collab & Cisplatin
28 Jan 2020 //
GLOBENEWSWIRE
Otonomy Presents Preclinical Results for GJB2 Gene Therapy Collab & Cisplatin
28 Jan 2020 //
GLOBENEWSWIRE
BridgeBio Pharma`s QED Therapeutics Receives Fast Track Designation
06 Jan 2020 //
GLOBE NEWSWIRE
Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA®
19 Oct 2019 //
BIOSPACE
Results from STELLAR Trial of Tumor Treating Fields with Chemotherapy
16 Oct 2019 //
BUSINESSWIRE
Roche`s Tecentriq excels in another lung cancer study
13 Sep 2019 //
ENDPOINTSNEWS
AstraZeneca’s Imfinzi tees up lung cancer fight with Roche
28 Jun 2019 //
FIERCE PHARMA
Novocure nets approval for electric-field mesothelioma therapy
24 May 2019 //
FIERCE BIOTECH
Clinical Data Presented of Bempegaldesleukin (NKTR-214) with Nivolumab
15 Feb 2019 //
PR NEWSWIRE
Roche`s lung cancer combo treatment wins FDA approval
07 Dec 2018 //
REUTERS
EMA Approves Cisplatin; List of nationally authorised medicinal products
05 Nov 2018 //
EMA
Genentech’s TECENTRIQ+Pemetrexed+Pt-Chemo Reduced Disease in Adv`d Lung Cancer
25 Sep 2018 //
BUSINESSWIRE
FDA Action Alert: Merck, Insmed and Antares Pharma
24 Sep 2018 //
Innovent presents clinical data of Sintilimab
20 Sep 2018 //
BIOSPECTRUM ASIA
JIANGSU YEW Pharmaceutical Co. Ltd. Fails EDQM Inspection
15 Sep 2018 //
EDQM
