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Enforcement Report - Week of December 11, 2024
11 Dec 2024 //
FDA
Eugia`s Generic Sunitinib Malate Receives Approval in the U.S.
14 Mar 2024 //
FDA
Novugen`s Generic Sunitinib Malate Receives Approval in the U.S.
21 Aug 2023 //
FDA
Cogent Bio Announces Positive Lead-In Data from Ongoing Phase 3 PEAK Trial
03 Jun 2023 //
GLOBENEWSWIRE
Amber Specialty Added to Pfizer’s Limited Distribution Network
03 Aug 2022 //
BUSINESSWIRE
Dr. Reddy`s Generic Sunitinib Maleate Receives Approval in the U.S.
11 Apr 2022 //
FDA
Teva Pharmaceutical`s Generic Sunitinib Maleate gets Approval in the U.S.
30 Nov 2021 //
FDA
Deciphera Receives EC Approval of QINLOCK for Gastrointestinal Stromal Tumor
22 Nov 2021 //
BUSINESSWIRE
SMC accepts Cabometyx/Opdivo combo for advanced kidney cancer patients
13 Oct 2021 //
PHARMATIMES
Exelixis: CABOMETYX in Combination with OPDIVO Provides Efficacy Benefits
16 Sep 2021 //
BUSINESSWIRE
Sun Pharm`s Generic Sunitinib Malate Receives Approval In the US
16 Aug 2021 //
FDA
Pimitespib Prolongs Survival in Refractory Gastrointestinal Stromal Tumour
07 Jun 2021 //
FIRSTWORLDPHARMA
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Superior
15 Feb 2021 //
BUSINESSWIRE
Glenmark Pharma launches generic sunitinib oral capsules
15 Feb 2021 //
PHARMABIZ
Sunitinib Malate by Medichem: manufactured in the EU, available worldwide
01 Sep 2020 //
PRESS RELEASE
A Policy Roadmap for Medicines Manufacturing Leadership
07 Jul 2020 //
PRESS RELEASE
FDA Approves First Drug for Fourth-Line Treatment of Gastrointestinal
15 May 2020 //
PRNEWSWIRE
Positive data keep Bristol Myers and Exelixis in the kidney cancer race
20 Apr 2020 //
BIOPHARMADIVE
Corporate Announcement 14.03.2020
14 Mar 2020 //
PRESS RELEASE
Bristol Myers Squibb announces updated results from phase 3 CheckMate -214
17 Feb 2020 //
PHARMABIZ
Immunicum AB (publ) Announces Publication of Abstracts for the 2020 ASCO-SITC
04 Feb 2020 //
GLOBENEWSWIRE
Q4`19 – Latest Authorizations by the Regulatory Agencies – Asia.
20 Jan 2020 //
PRESS RELEASE
Keytruda combo bags EU approval in RCC
06 Sep 2019 //
PHARMATIMES
Immunicum’s ilixadencel successful in kidney cancer
30 Aug 2019 //
PHARMATIMES
Deciphera success sets up 2-horse race in gastrointestinal cancer
14 Aug 2019 //
BIOPHARMADIVE
Deciphera soars as phase 3 cancer data tee up FDA filing
13 Aug 2019 //
FIERCE BIOTECH
Roche/Exelixis` Cotellic fizzles in pivotal melanoma study
21 Jun 2019 //
ENDPTS
Merck`s Keytruda wins FDA approval as combination therapy for kidney cancer
23 Apr 2019 //
REUTERS
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Inlyta®
22 Apr 2019 //
BUSINESSWIRE
FDA Accepts sBLA & Grants Priority Review for BAVENCIO+INLYTA
13 Feb 2019 //
PR NEWSWIRE
Merck, Pfizer combo treatment boosts kidney cancer survival
12 Feb 2019 //
REUTERS
Deciphera CBO Morl talks lines of therapy for kinase inhibitor ripretinib
11 Jan 2019 //
FIERCE BIOTECH
Roche yanks Tecentriq kidney cancer applications as Merck, Pfizer
21 Nov 2018 //
FIERCE PHARMA
Blueprint posts `impressive` data for lead candidate, but investors tepid
17 Nov 2018 //
BIOPHARMA DIVE
Merck KGaA, Pfizer`s immuno-drug shown to alleviate kidney cancer
12 Sep 2018 //
REUTERS
NICE u-turn recommends Ipsen’s Cabometyx for kidney cancer
29 Aug 2018 //
PHARMA TIMES
NICE rules against first-line use of Ipsen’s Cabometyx
05 Jun 2018 //
PHARMA TIMES
EU OKs first-line use of Ipsen’s Cabometyx
17 May 2018 //
PHARMATIMES
Enforcement Report - Week of May 16, 2018
16 May 2018 //
FDA
Six medicines recommended for approval, including one orphan
24 Mar 2018 //
EMA
Five new medicines backed for EU approval
26 Feb 2018 //
PHARMA TIMES
Five medicines recommended for approval, including two orphans
23 Feb 2018 //
EMA
Pfizer defends kidney-cancer position with Bavencio `breakthrough`
04 Jan 2018 //
FIERCE PHARMA
FDA’s year-end approvals take annual tally to 46
02 Jan 2018 //
PMLIVE
Bayer’s Stivarga wins NICE approval for GIST
20 Nov 2017 //
PHARMA TIMES
Bristol-Myers Squibb Combination Treatment Not At The End Of The Crossroad
17 Aug 2017 //
SEEKING ALPHA
Bristol-Myers Squibb shares slip as kidney cancer drug trial falls short of goal
15 Aug 2017 //
MARKET WATCH
Pfizer Announces Acceptance of Regulatory Submissions by USFDA & EMA for SUTENT
01 Jun 2017 //
PRESS RELEASE
Cancer drugs Tarceva and Sutent hold Ebola and dengue at bay in mice
28 Feb 2017 //
FIERCE BIOTECH
New Drug Beats Standard Therapy in Advanced Kidney Cancer
18 Nov 2016 //
DDDMAG
Pfizer Lines up Three Experimental I/O Meds for NCI Research Tie-up
15 Nov 2016 //
FIERCE BIOTECH
Bayer seeks expanded marketing nod from US, Japan & EU
08 Nov 2016 //
PHARMABIZ
Exelixis Could Pose a Huge Threat to Biotech Giants Bristol and Pfizer
18 Oct 2016 //
BIOSPACE
Ipsen eyes first-line licence for new advanced kidney cancer drug Cabometyx
11 Oct 2016 //
PMLIVE
Data backs broader use of Pfizer’s Sutent in kidney cancer
11 Jul 2016 //
PHARMATIMES
Successful BE study paves way for AqVida to launch first generic Sunitinib capsules
23 May 2016 //
PRESS RELEASE
Pfizer to trial triple-threat cancer cocktail therapy
11 May 2016 //
FIERCE BIOTECH
Two new drugs are registered by Anvisa
28 Dec 2015 //
ANVISA
AqVida crowns innovative first decade with robotic filling breakthrough
23 Sep 2015 //
PRESS RELEASE
