- Spark Newswire

1 minute read

Verrica Holds Type A Meeting With FDA For Potential Approval Of Skin Infection Candidate

Today, 9:29 AM

The U.S. Food and Drug Administration (FDA) convened a Type A meeting with Verrica Pharmaceuticals (NASDAQ: VRCA) regarding the course of action for the clearance of its drug candidate VP-102.

VRCA

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Schrödinger’s Initial-Stage Cancer Study Gains FDA Clearance

By Ragothaman Srinivasan

Today, 9:29 AM

Schrödinger Inc. (NASDAQ: SDGR) announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate SGR-1505 in patients with relapsed or refractory B-cell lymphoma.

SDGR

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Gilead Again Seeks HIV Drug Approval From FDA After Addressing Vial Compatibility Issues

By Ragothaman Srinivasan

Today, 9:29 AM

Gilead Sciences (NASDAQ: GILD) resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection.

GILD

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Kezar Life Shares Shoot Higher After Positive Results From Mid-Stage Study Of Kidney Disease Candidate

By Ragothaman Srinivasan

Today, 9:29 AM

Kezar Life Sciences, Inc. (NASDAQ: KZR) reported positive topline results from the MISSION Phase 2 clinical trial evaluating zetomipzomib in patients with active lupus nephritis (LN).

KZR

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Eliem Concludes Patient Enrolment In Mid-Stage Study Of Radicular Back Pain Drug

By Ragothaman Srinivasan

Today, 9:29 AM

Eliem Therapeutics (NASDAQ: ELYM) has completed dosing of the last patient in its Phase 2a trial of ETX-810 in patients with chronic lumbosacral radicular pain (LSRP).

ELYM

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U.S. FDA Accepts Emergent’s Anthrax Vaccine Candidate Filing For Review

By Ragothaman Srinivasan

Today, 9:29 AM

The U.S. Food and Drug Administration (FDA) has accepted to review Emergent BioSolutions’ (NYSE: EBS) Biologics License Application (BLA) for its new anthrax vaccine candidate AV7909. The regulatory agency sets the Prescription Drug User Fee Act (PDUFA) goal date for a decision in month of April 2023.

EBS

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Calithera Commences Mid-Stage Study Of DLBCL Candidate

By Ragothaman Srinivasan

Today, 9:29 AM

Calithera Biosciences, Inc. (NASDAQ: CALA) initiates dosing first patient in the phase 2 clinical trial evaluating its spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

CALA

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Sarepta Therapeutics’ Shares Plummet Following FDA’s Clinical Hold On MOMENTUM Study

By Ragothaman Srinivasan

Today, 9:29 AM

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on SRP-5051 (vesleteplirsen), Sarepta Therapeutics' (NASDAQ: SRPT) lead candidate to treat patients with Duchenne muscular dystrophy.

SRPT

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BioNTech Gets EMA’s Priority Medicines Status For Testicular Cancer Drug

By Ragothaman Srinivasan

Today, 9:29 AM

BioNTech (NASDAQ: BNTX) received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its product candidate BNT211 in the third- or later-line treatment of testicular germ cell tumors.

BNTX

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BridgeBio Pharma Reveals Early Positive Data For Canavan Disease

By Ragothaman Srinivasan

Today, 9:29 AM

BridgeBio Pharma (NASDAQ: BBIO) announced early positive data from the the first two participants dosed in CANaspire clinical study for the treatment of Canavan disease.

BBIO