FDA Approval

LyGenesis Announces First Patient Dosed in its Phase 2a Clinical Trial of a First-in-Class Regenerative Cell Therapy for Patients with End-Stage Liver Disease

Allogenic Regenerative Cell Therapy for End-Stage Liver Disease

2 min read

LyGenesis Announces First Patient Dosed in its Phase 2a Clinical Trial of a First-in-Class Regenerative Cell Therapy for Patients with End-Stage Liver Disease

LyGenesis, a clinical-stage biotechnology company developing cell therapies for large unmet medical needs, announced today that the...

NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression

NeuroStar Advanced Therapy FDA Clearance

2 min read

NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression

Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve...

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

2 min read

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today...

Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity

mage showing a person walking outdoors, symbolizing cardiovascular health and exercise.

2 min read

Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication...

Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery

A bottle and dropper of clobetasol propionate ophthalmic suspension with an eye in the background.

1 min read

Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery

Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug...

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

3 min read

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration...

Everest Medicines’ Partner Pfizer Announces European Commission Approves VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

2 min read

Everest Medicines’ Partner Pfizer Announces European Commission Approves VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s partner Pfizer Inc. (NYSE: PFE) announced that the European Commission...

Melanoma Research Alliance Applauds FDA Approval of First Cellular Therapy in Melanoma

FDA Approves AMTAGVI for Melanoma Treatment

2 min read

Melanoma Research Alliance Applauds FDA Approval of First Cellular Therapy in Melanoma

The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the U.S. Food...

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

"FDA Approval for Onivyde NALIRIFOX Regimen"

2 min read

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved...

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

"Outlook Therapeutics NORSE EIGHT Trial Image"

2 min read

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic...

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FDA Approval

LyGenesis Announces First Patient Dosed in its Phase 2a Clinical Trial of a First-in-Class Regenerative Cell Therapy for Patients with End-Stage Liver Disease

NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity

Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Everest Medicines’ Partner Pfizer Announces European Commission Approves VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Melanoma Research Alliance Applauds FDA Approval of First Cellular Therapy in Melanoma

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

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