Nasdaq5d
J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...
Nasdaq5d
ImmunityBio Provides Update On FDA Submissions For 2025
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq4d
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 ...
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.
Nasdaq5d
FDA Approves LUMAKRAS With Vectibix For KRAS G12C-Mutated MCRC
(RTTNews) - Amgen, Inc. (AMGN) a biopharmaceutical company on Friday, announced that the FDA has approved LUMAKRAS or sotorasib in combination with Vectibix or panitumumab for the treatment of ...
Nasdaq4d
FDA Approves AstraZeneca's Calquence For Patients With Untreated Mantle Cell Lymphoma
(RTTNews) - AstraZeneca (AZN), on Friday, announced that the FDA has approved CALQUENCE in ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Nasdaq3d
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq8d
22nd Century Group Supports FDA's Proposed Reduced Nicotine Content Standard Following OMB Review Completion
The FDA spokesperson indicated that the policy could ... 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should ...
Nasdaq11d
Pharma Stock Roundup: FDA Updates for JNJ, GSK, PFE, NVO's Expanded Deal
The FDA granted priority review designation to J&J’s biologics license application (BLA) seeking approval of nipocalimab for antibody-positive patients with gMG, a rare, autoantibody-driven disease.
Nasdaq11d
FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab
Johnson & Johnson JNJ announced that the FDA has accepted its regulatory filing seeking the FDA’s approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in ...
Nasdaq11d
Revvity Reports FDA Clearance For EUROIMMUN's Automated Chemiluminescence-based Immunoassay Test
(RTTNews) - Revvity (RVTY) received 510(k) clearance from FDA for EUROIMMUN's automated ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Nasdaq11d
FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib
Exelixis, Inc. EXEL announced that the FDA has notified it about an update to its supplemental new drug application (sNDA) for cabozantinib. The sNDA is seeking approval for cabozantinib for the ...