Ophthalmology Times

Conavi Medical submits Novasight Hybrid IVUS/OCT System to FDA for 510(k) clearance

Conavi Medical has submitted its Novasight Hybrid™ IVUS/OCT intravascular imaging system to the US Food and Drug ...
Precision Medicine Online

FDA Mulling Existing Data Types Sponsors May Leverage to Speed Cell, Gene Therapies to Market

The agency held a meeting to gather drugmakers' perspectives as it considers a draft guidance on how previously generated ...
Ophthalmology Times

FDA approves abbreviated new drug application from Amneal Pharmaceuticals for bimatoprost ophthalmic solution 0.01%

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' Abbreviated New Drug Application (ANDA) for ...
BioSpace

After FDA Rejection, Lexicon’s Type 1 Diabetes Drug Hit With Another Regulatory Delay

An advisory committee last year found that Zynquista’s benefit-risk profile in type 1 diabetes was unfavorable due to cases ...
BioSpace

FDA Details Thinking for Streamlining Development of Cell, Gene, Regenerative Therapies

Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the ...

FDA Accepts New Drug Application for Corcept Therapeutics’s (CORT) Relacorilant

Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the Best Performing Long Term Stocks According to Analysts. On September 10, Corcept Therapeutics Incorporated (NASDAQ:CORT) announced that ...

Actuate Therapeutics Provides FDA with Updated Clinical Data Package to Support Planned Regulatory Interactions with FDA and EMA Over the Coming Months

Elraglusib represents a potential back bone therapy in pancreatic cancer with three ongoing trials in combination with current standards of care ...

US News Live: Georgia senators demand answers on deaths in immigration detention

Welcome to our live blog tracking the latest news and developments from the United States. Stay updated with real-time ...