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The Latest Breaking News from FDA

Sarepta Reports One Heart Inflammation Case In Duchenne Gene Therapy Trial

Sarepta Therapeutics Inc (NASDAQ:SRPT) shared new functional data across multiple studies from the SRP-9001 (delandistrogene moxeparvovec) program for Duchenne muscular dystrophy. SRP-9001 is an investigational gene therapy under development in partnership with Roche Holdings AG (OTC:RHHBY). Results from Cohort 1 demonstrated a 3.8-point improvement and 3.2-point improvement on the Duchenne functional scale 52 weeks after…

Benzinga

Coherus's Refiling For Head and Neck Cancer Candidate Accepted By FDA For Review

Coherus BioSciences (NASDAQ: CHRS) announced that the United States Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for Toripalimab in combination with Gemcitabine and Cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasophar

Benzinga

The Daily Biotech Pulse: FDA Decision On Biogen Alzheimer's Drug Due In January, FDA Reviews Roche's Lymphoma Candidate, Rare Pediatric Tag For Kazia's Pediatric Brain Cancer Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

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InflaRx's Stock Gains Following FDA Fast Track Status To Skin Disease Drug

The US Food and Drug Administration (FDA) granted a Fast Track designation to InflaRx’s (NASDAQ: IFRX) lead candidate Vilobelimab for the treatment of ulcerative Pyoderma Gangrenosum (PG).

Benzinga

Benzinga Before The Bell: FDA Temporarily Suspends Juul Ban, FTX Wants Bitcoin Derivatives, Voyager Digital Files For Chapter 11 Bankruptcy And Other Top Financial Stories Wednesday, July 6

CNBC Ben & Jerry’s Sues Parent Unilever On Israeli business Sale

Benzinga

Kazia Shares Shoot Higher As FDA Grants Rare Pediatric Disease Designation To Brain Cancer Candidate

The United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia Therapeutics’ (NASDAQ: KZIA) lead drug Paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT).

Benzinga

FDA Temporarily Suspends Banning Order On Juul's E-Cigarettes

The FDA temporarily suspended its ban on sales of the popular e-cigarette maker Juul, backed by Altria Group Inc

Benzinga

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Alphabet, Dyne Therapeutics And 74 Biggest Movers From Yesterday

Gainers Enjoy Technology, Inc. (NASDAQ: ENJY) shares jumped 81.5% to close at $0.31 on Tuesday.

Benzinga

AP News Digest 3 a.m.

Here are the AP’s latest coverage plans, top stories and promotable content. All times EDT. For up-to-the minute information on AP’s coverage, visit Coverage Plan at https://newsroom.ap.org.

The Independent UK

The FDA Perversely Seeks To Make Both Cigarettes and Harm-Reducing Alternatives Less Appealing

The agency’s policies would boost the black market and smoking-related deaths.

Reason

FDA temporarily suspends order banning Juul cigarettes

The Food and Drug Administration has issued an administrative stay on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market

The Independent UK

What's In A Name?

A doctrine by any other name would be just as major.

Reason

What Is The Role Of The FDA In Measures Taken By Hawaii Officials Against A CBD Company?

The Hawaii Department of Health (DOH) and Hawaii Department of Public Safety (PSD) conducted operations to execute search warrants and to embargo products at several retail stores including a CBD dispensary in Honolulu, reported

Benzinga

Tesla, Ra Medical Systems And 51 Stocks Moving In Tuesday's Mid-Day Session

Gainers Ra Medical Systems, Inc. (NASDAQ: RMED) shares jumped 69.6% to $0.5240 after the company announced it has received FDA 510(k) clearance for its DABRA 2.0 catheter.

Benzinga

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Benzinga

Why Precigen Shares Are Gaining Today

Precigen Inc (NASDAQ:PGEN) has agreed to sell its subsidiary Trans Ova Genetics, an animal reproductive technologies company, to URUS, a holding company with cooperative and private ownership. The deal consideration includes $170 million in upfront cash and up to $10 million earn-out based on the performance of Trans Ova in 2022 and 2023. …

Benzinga

Dyne's Shares Gain After FDA Removed Clinical Hold On Muscular Disease Study

Dyne Therapeutics (NASDAQ: DYN) announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared its Investigational New Drug (IND) application to initiate a clinical trial of its drug DYNE-25.

Benzinga

What's Going On With Dyne Therapeutics Shares Today?

Dyne Therapeutics Inc (NASDAQ: DYN) shares are trading lower by 5.42% to $6.81 after the company announced FDA clearance of its Investigational New Drug application for DYNE-251 for the treatment of Duchenne muscular dystrophy.

Investors Business Daily

Why IPO Stock Amylyx Pharmaceuticals Is Beginning To Heat Up — Again

IPO stock Amylyx Pharmaceuticals jumped Monday as the Food and Drug Administration prepares to review its controversial ALS treatment again.

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Benzinga

Titan Pharmaceuticals Gets FDA Clearance To Commence Opioid Disorder Study

The U.S. Food and Drug Administration (FDA) has cleared Titan Pharmaceuticals’ (NASDAQ: TTNP) Investigational New Drug (IND) application for the Phase 1 study of its drug candidate Nalmefene.

Benzinga

Benzinga Pro's Top 5 Stocks To Watch For Tuesday, Jul. 5, 2022: RMED, RBCN, LEVI, DAL, TSM

Today's 5 Stock Ideas: Ra Medical Systems (RMED) - Shares up 55.5% premarket. The company announced it has received FDA 510(k) clearance for its DABRA 2.0 catheter. Rubicon Technology (RBCN) - Shares up

Tribune News Service

How Pfizer won the pandemic, reaping outsize profit and influence

The grinding two-plus years of the pandemic have yielded outsize benefits for one company — Pfizer — making it both highly influential and hugely profitable as COVID-19 continues to infect tens of thousands of people and kill hundreds each day.

Bangkok Post

40 tonnes of drugs to go up in smoke this week

The Food and Drug Administration (FDA) and narcotics suppression authorities on Monday inspected more than 40 tonnes of confiscated illegal drugs worth over 34.6 billion baht before they are incinerated at a designated facility this week.

The Guardian - UK

Parliament an unsafe workplace due to sexual misconduct by MPs, say unions

Political parties cannot be trusted to deal with misbehaviour by their own MPs, claim general secretaries

The Street

The Sarepta Therapeutics Pipeline No One is Talking About

Gene therapy and gene editing get all the glory, but investors shouldn't overlook an emerging group of tools.

The Independent UK

Medication abortion is common; here's how it works

Medication abortions were the preferred method for ending pregnancy in the U.S. even before the Supreme Court overturned Roe v. Wade

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