FDA Approvals
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The regulator greenlit 55 new drugs last year, seven of which belonged to Pfizer, including an ulcerative colitis treatment and a migraine nasal spray—both acquired in multibillion-dollar buys.
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It wasn't a merry end to 2023 for Amgen or Zealand Pharma, which received Complete Response Letters for Lumakras and for dasiglucagon in congenital hyperinsulinism.
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Pasithea Therapeutics Announces FDA Acceptance of IND Application to Evaluate PAS-004 in Advanced Cancer Patients
1/2/2024
Pasithea Therapeutics Corp. today announced the Investigational New Drug Application (IND) clearance to proceed by the U.S. Federal Drug Administration (FDA) to evaluate PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors.
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Pulnovo Medical Announces PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval
1/2/2024
Pulnovo Medical Limited recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and approval from China's National Drug Administration (NMPA) for the PADN Catheter and Generator.
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CVRx receives FDA approval for expanded labeling of BarostimU.S. annual market opportunity increases based on real world adoption and strength of long-term BeAT-HF data
12/26/2023
CVRx, Inc. announced that the U.S. Food and Drug Administration has approved revised Instructions For Use for Barostim incorporating key long-term clinical data from the BeAT-HF randomized clinical trial.
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Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
12/26/2023
Coherus BioSciences, Inc. announced that the U.S. Food and Drug Administration approved UDENYCA ONBODY™, the company's on-body injector presentation of UDENYCA®, a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
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Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs
12/26/2023
Jemincare announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration and 2 approvals from the U.S. Food & Drug Administration.
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Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
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Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
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FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)
12/22/2023
BeiGene, Ltd. today announced the U.S. Food and Drug Administration (FDA) has approved a label update for BRUKINSA® (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
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Senti Bio Announces FDA Clearance of IND Application for SENTI-202 for the Treatment of Relapsed or Refractory Hematologic Malignancies Including Acute Myeloid Leukemia
12/22/2023
Senti Biosciences, Inc. today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for SENTI-202.
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The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
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WAINUA™ (eplontersen) granted regulatory approval in the U.S. for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis
12/21/2023
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca's WAINUA™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN.
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U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data
12/21/2023
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase 3 ZUMA-7 study.
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4DMT Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for 4D-150 Genetic Medicine for Intravitreal Treatment of Wet AMD, the First RMAT Designation in Wet AMD
12/21/2023
4D Molecular Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD).
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SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
12/21/2023
SELLAS Life Sciences Group, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, the Company’s novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL).
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Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
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Everest Medicines' Partner Calliditas Therapeutics Announces Nefecon® the Only FDA-approved Treatment for IgA Nephropathy to Significantly Slow Kidney Function Decline
12/20/2023
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. Food and Drug Administration (FDA) had approved Nefecon® delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
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Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function
12/20/2023
Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
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Terran Biosciences Receives FDA Clearance for NM-101, the industry’s first software for the analysis of neuromelanin-sensitive MRI
12/20/2023
Terran Biosciences, Inc. has received FDA clearance to market NM-101, a cloud-based software platform to analyze neuromelanin-sensitive MRI scans. Currently, there is no other FDA-cleared software indicated for the analysis of neuromelanin MRI on the market, making Terran’s technology the world’s first.