Newsfeeds - Spark Newswire

4 minute read

Biotech Investors: August’s Key PDUFA Catalysts You Must Know

Today, 2:51 AM

Regulatory decisions have yet to pick up pace this year. July’s calendar was light, but the good news was that most decisions turned out to be positive. That said, none of the drugs approved during the month were new molecular entities, underlining a lack of innovation going on in the sector.

ACAD

1 minute read

Horizon Therapeutics Receives FDA Approval For Uncontrolled Gout Candidate

By Ragothaman Srinivasan

Today, 2:51 AM

The U.S. Food and Drug Administration (FDA) has approved Horizon Therapeutics’ (NASDAQ: HZNP) supplemental Biologics License Application (sBLA) for expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, in patients with uncontrolled gout.

HZNP

12 minute read

Stocks That Hit 52-Week Lows On Friday

By Benzinga Insights

Today, 2:51 AM

On Friday, 319 stocks hit new 52-week lows.

ADI

4 minute read

Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

By Shanthi Rexaline

Today, 2:51 AM

The biotech sector is poised to end June on a positive note, despite largely disappointing regulatory decisions scheduled during the month, thanks to a reversal in broader market sentiment.

ACER

2 minute read

Horizon Therapeutics plc Submits Regulatory Filing For UPLIZNA (inebilizumab) In Brazil

By Bill Haddad

Today, 2:51 AM

Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has submitted a regulatory filing to the Brazil National Health Surveillance Agency (ANVISA) for UPLIZNA for the treatment of adult patients with

HZNP

4 minute read

FDA
News

Horizon Therapeutics To Highlight Data And Education On Thyroid Eye Disease At The Endocrine Society 2022 Annual Conference

By Benzinga Newsdesk

Today, 2:51 AM

Horizon Therapeutics plc to Highlight Data and Education on Thyroid Eye Disease (TED) at the Endocrine Society (ENDO) 2022 Annual Conference -- Poster presentation will share results from the Phase 2 and Phase 3

HZNP

5 minute read

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

By Shanthi Rexaline

Today, 2:51 AM

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and Drug Administration approved by May 2021.

ACAD

3 minute read

The Week Ahead In Biotech (May 30-June 4): FDA Decision For Eton’s Partnered Epilepsy Drug, ASCO Conference Gets Underway And More

By Shanthi Rexaline

Today, 2:51 AM

Biotech stocks advanced in the week ended May 27, tracking the overall positive sentiment of the broader market. Notwithstanding the week's strength, the sector has been one of the worst performers for the year-to-date period.

ABBV

1 minute read

SVB Leerink Initiates Coverage On Horizon Therapeutics with Market Perform Rating, Announces Price Target of $95

By Benzinga Newsdesk

Today, 2:51 AM

SVB Leerink analyst David Risinger initiates coverage on Horizon Therapeutics (NASDAQ:HZNP) with a Market Perform rating and announces Price Target of $95.

HZNP

10 minute read

Benzinga’s Top Ratings Upgrades, Downgrades For May 23, 2022

By Benzinga Insights

Today, 2:51 AM

ABBV