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SpringWorks Therapeutics Inc (SWTX) Announces PDUFA Date Extension for Nirogacestat NDA

SpringWorks Therapeutics Inc (SWTX) Announces PDUFA Date Extension for Nirogacestat NDA
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United statesSamantha hilson sandlerSaqib islamDesmoid working groupDesmoid tumor working groupBone sarcoma groupEuropean medicines agencyEuropean organization for researchEuropean commissionEuropean consensus initiativeSpringworks therapeutics incDrug administrationWorks therapeuticsPrescription drug user fee actNew drug applicationMajor amendment

Live from ASCO 2023 | For the Third Consecutive Year, Ascentage Pharma Releases Promising Results of Alrizomadlin plus Pembrolizumab in Patients with Cutaneous Melanoma that Failed Immuno-Oncologic (IO) Therapies

SUZHOU, China, and ROCKVILLE, Md., June 5, 2023 /PRNewswire/ Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has released updated results from a Phase II study of MDM2-P53 inhibitor, alrizomadlin (APG-115), in combination with pembrolizumab in patients with unresectable or.

United statesSan antonioUniversity of texasWestern australiaHong kongAscentage pharmaYifan zhaiPrnewswire ascentage pharmaMontaserf shaheenMd anderson cancer centerMajor nationalDana farber cancer instituteChina national medical products administrationUniversity of texas health science centerAmerican society of clinical oncologyNational reimbursement drug list

U S Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb s Application for Repotrectinib for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

Application based on results from the registrational TRIDENT-1 trial, in which repotrectinib demonstrated high response rates and durable responses in patients with ROS1-positive locally advanced or. | May 30, 2023

Jonathan chengBristol myers squibbBristol myers squibb companyDrug administrationNew drug applicationPriority reviewPrescription drug user fee actBristol myersMyers squibbPoint therapeuticsBlinded independent central reviewBetter futureOrphan drugBreakthrough therapy designationsStatement regarding forward lookingBristol myers squibb company stock exchange

SpringWorks Therapeutics Announces Full Enrollment of Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian Granulosa Cell Tumors

STAMFORD, Conn., May 30, 2023 SpringWorks Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and. | May 30, 2023

Saqib islamSamantha hilson sandlerNational cancer instituteDana farber cancer instituteFred hutchinson cancer research centerDrug administrationEuropean commissionSpringworks therapeutics incWorks therapeuticsChief executive officerResponse evaluation criteriaSolid tumorsNew drug applicationTime oncology reviewPriority reviewPrescription drug user fee act

Ipsen receives CHMP negative opinion, following re-examination of potential first FOP treatment in the E U

Palovarotene is the first medicine to be submitted for regulatory approval for fibrodysplasia ossificans progressiva , an ultra-rare disease with an estimated prevalence of 1.36 per million. | May 26, 2023

France generalUnited kingdomUnited statesNicolas boglerHoward mayerAnna gibbinsIoana piscociuAl mukaddamAmy wolfGenevieve baujatIpsen euronextHead of corporate brand strategy communicationsProc intl clin councilGlobal head of franchise communicationsEuropean medicines agencyCommittee for medicinal products human use