Nasdaq3d
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), in patients with a certain type of breast cancer. The drug, developed ...
Nasdaq4d
Amgen's Lumakras Gets FDA Nod for Expanded Use in Colorectal Cancer
Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated ...
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Sanofi's Opella: FDA Lifts Clinical Hold On OTC Cialis Trial
(RTTNews) - Sanofi's Consumer Healthcare division, Opella, announced that the U.S. Food and Drug Administration has lifted a clinical hold on its planned actual use trial (AUT). The trial is aimed ...
Nasdaq3d
Disc Medicine to Host Conference Call on FDA Feedback for Bitopertin Development in Erythropoietic Protoporphyria
Disc Medicine, Inc. will hold a conference call on January 21, 2025, at 8:00 am EST to discuss feedback from the FDA regarding its investigational drug, bitopertin, for treating Erythropoietic ...
Nasdaq6d
INNOVATE Corp. Announces FDA Approval of MediBeacon® Transdermal GFR System for Kidney Function Assessment
The FDA has approved MediBeacon®'s TGFR system for noninvasive kidney function assessment, targeting both normal and impaired renal patients. INNOVATE Corp. announced the FDA approval of the ...
Nasdaq3d
Scilex Holding Company Files Quarterly Report and Anticipates Compliance with Nasdaq Listing Requirements
Scilex Holding Company has filed its Quarterly Report on Form 10-Q, indicating progress in financial reporting and corporate governance. The company expects to regain compliance with Nasdaq ...
Nasdaq6d
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
(RTTNews) - The U.S. Food and Drug Administration approved AstraZeneca (AZN, AZN.L) and Daiichi Sankyo's (DSKYF.PK) Datroway (datopotamab deruxtecan-dlnk) for the treatment of adult patients with ...
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Amgen's Lumakras+Vectibix Combo Gets FDA Approval For Metastatic Colorectal Cancer Treatment
(RTTNews) - Amgen Inc. (AMGN), Friday announced that the U.S. Food and Drug Administration has approved its Lumakras plus Vectibix combination therapy for the treatment of patients with KRAS G12C ...
2 Healthcare Stocks You Can Buy Right Now Before They Surge Even Higher
Generally, you can count on drugmakers for a steady revenue performance -- since patients need their medicines, revenue holds ...
Nasdaq6d
Pharma Stock Roundup: J&J's ITCI Buyout, LLY's Weak Q4 Sales
JNJ will buy Intra-Cellular Therapies, producer of a drug for bipolar disorder, for $14.6 billion. Eli Lilly (LLY) announced disappointing preliminary sales numbers, lowering its investor guidance ...
Atara extends losses after FDA clinical hold
Atara Biotherapeutics (ATRA) stock slips as company faces an FDA clinical hold after rejection of lead candidate Ebvallo.
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...