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Intellia's (ntla) ind for gene-editing therapy gets fda clearance

Intellia (NTLA) gets FDA nod to begin a phase III study on its gene editing candidate, NTLA-2001 to treat transthyretin amyloidosis with cardiomyopath...

October 19, 2023, 12:47 pm

Jasper (jspr) up on fda nod to begin early-stage urticaria study

Jasper (JSPR) announces the fda clearance to begin the clinical study of briquilimab for chronic sponta...

October 10, 2023, 9:01 am

Nrx pharma (nrxp) to initiate clinical study on nrx-101, stock up

NRx Pharma (NRXP) receives fda clearance to begin clinical development for its lead candidate, NRX-101,...

October 3, 2023, 10:31 am

Femasys inc. receives u.s. fda clearance to market femaseed, an innovative infertility treatment solution

– The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal ...

September 25, 2023, 9:25 pm

Ttoo stock alert: t2 confirms fda clearance for biothreat panel

T2 Biosystems (NASDAQ: TTOO ) stock can officially be added to an unfortunate list that includes fellow meme stocks Mullen Automotive (NASDAQ: MULN )...

September 19, 2023, 3:51 pm

Ideaya's triple threat: melanoma, money, and momentum

IDEAYA Biosciences specializes in precision oncology, has fda clearance for a Phase 1/2 trial, and part...

September 13, 2023, 6:19 am

Uniqure announces fda clearance of investigational new drug application for amt-260 gene therapy for refractory mesial temporal lobe epilepsy

Clinical trial initiation expected in the fourth quarter of 2023 LEXINGTON, Mass. and AMSTERDAM, Sept. 05, 2023 (GLOBE NEWSWIRE) — uniQure N.V. (NAS...

September 5, 2023, 11:05 am

23andme granted new fda clearance to report additional brca variants

510(k) clearance will allow 23andMe to report an additional 41 genetic variants in the BRCA1 and BRCA2 genes that increase risk for breast, ovarian, p...

August 31, 2023, 5:28 pm

Fresenius medical's (fms) new hhd device to increase portability

Fresenius Medical (FMS) gets fda clearance for Versi HD with GuideMe Software, a portable, home hemodia...

August 24, 2023, 9:46 am

Vincerx pharma receives fda clearance for early-stage leukemia trial

Vincerx Pharma shares moved higher after the biopharmaceutical company announced it has received Investigational New Drug (IND) clearance from the U.S...

August 22, 2023, 10:09 am

Smith & nephew: entering new markets but growth is slow still

Smith & Nephew plc is a long-standing company in the medical device sector, focusing on developing and manufacturing internationally. The company has ...

August 1, 2023, 4:44 am

Inspire medical systems: revolutionizing obstructive sleep apnea treatment

Inspire Medical Systems has reported a significant 84% rise in Q1 2023 revenue, reaching $127.9 million, driven by its innovative treatments for Obstr...

July 19, 2023, 2:17 pm

Tandem diabetes (tndm) gets fda nod for tandem mobi system

Tandem Diabetes (TNDM) receives fda clearance for the world's smallest AID system, Tandem Mobi....

July 12, 2023, 10:20 am

C4 therapeutics announces fda clearance of investigational new drug application for cft8919, an orally bioavailable bidac™ degrader targeting egfr l858r for non-small cell lung cancer

WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated ...

July 5, 2023, 11:00 am

Haemonetics (hae) gets fda clearance for nexsys pcs upgrades

Haemonetics (HAE) receives fda clearance for the advancements made to the NexSys PCS plasma collection ...

June 23, 2023, 8:54 am

Replay and md anderson announce fda clearance of ind application for first-in-class t-cell receptor natural killer (tcr-nk) cell therapy for sarcoma

Replay and MD Anderson announce fda clearance of IND application for first-in-class T–Cell Receptor N...

June 20, 2023, 11:00 am

Teleflex receives fda clearance for the wattson® temporary pacing guidewire

Company expands Structural Heart Portfolio with the first commercially available bipolar temporary pacing guidewire designed specifically for use duri...

June 7, 2023, 10:30 am

Pfizer secures fda clearance for rsv vaccine in older adults

Pfizer Inc (NYSE:PFE) has gained approval from the US Food and Drug Administration (FDA) for its respiratory syncytial virus (RSV) vaccine in older ad...

June 1, 2023, 12:26 pm

Thermo fisher (tmo) gets fda clearance for its immunoassays

Thermo Fisher (TMO) announces the fda clearance of its blood-based biomarkers used in the determination...

May 22, 2023, 9:04 am

Thermo fisher receives fda clearance for preeclampsia risk assessment tool

Thermo Fisher Scientific (NYSE:TMO) announced that the U.S. Food and Drug Administration (FDA) has cleared its Thermo Scientific B·R·A·H·M·S PlG...

May 19, 2023, 9:27 am


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