Zephyrnet Logo

Tag: NDA

Positive Phase III Bridging Trial of Hexvix, a Diagnostic Drug for Bladder Cancer – Drugs.com MedNews

SHANGHAI, Aug. 11, 2023 /PRNewswire/ -- Asieris Pharmaceuticals, a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of...

Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

Treatment for: MucositisGalera Receives Complete Response Letter from U.S. FDA for Avasopasem ManganeseMALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq:...

Clinical Research Phases and the Path to Drug Approval – Imperial Clinical Research Services Blog

Getting a drug from the bench to the bedside takes around 10-15 years and around 6-7 of those years are spent in clinical trials....

Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole

Treatment for: Skin and Structure InfectionBasilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic CeftobiproleAllschwil,...

S3 Ep145: Bugs With Impressive Names!

by Paul Ducklin ONE WEEK, TWO BWAINS Apple patches two zero-days, one for a second time. How a 30-year-old cryptosystem got...

Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

Treatment for: Nonalcoholic SteatohepatitisMadrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver FibrosisCONSHOHOCKEN,...

Amneal Receives U.S. FDA Complete Response Letter for IPX203

Generic name: carbidopa and levodopaTreatment for: Parkinson's DiseaseAmneal Receives U.S. FDA Complete Response Letter for IPX203BRIDGEWATER, N.J.--(BUSINESS WIRE) July 03, 2023 --Amneal Pharmaceuticals, Inc....

Lessons Learned Scaling to $5B With Cockroach Labs’ CEO

A couple of weeks back I had a chance to hop across the pond, spending a few days at SaaStr and the Pavilion CRO...

Aldeyra Therapeutics Provides Regulatory Update on ADX-2191

Generic name: methotrexateTreatment for: Primary Vitreoretinal LymphomaAldeyra Therapeutics Provides Regulatory Update on ADX-2191LEXINGTON, Mass.--(BUSINESS WIRE)--Jun. 21, 2023-- (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted...

Santhera licences vamorolone rights to Catalyst Pharmaceuticals

Santhera Pharmaceuticals Holding has exclusively granted the rights to commercialise its Duchenne muscular dystrophy drug vamorolone in North America to Catalyst Pharmaceuticals...

Top 5 Blockchain Marketing Agencies For 2023

Developing an in-house marketing department might be challenging, especially for start-ups. Headhunting, staff training, and team building require significant resources; only some young companies...

How to find research studies near you and frequently asked questions about participating in a clinical trial

For those interested in learning more about how to take part in clinical research studies, finding the right trial may be simpler than it...

Latest Intelligence

spot_img
spot_img