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The Latest Breaking News from FDA

Philips' Ventilator Woes Continue With Another FDA Class I Recall

Koninklijke Philips NV's (NYSE: PHG) Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts put together using an expired adhesive.

Benzinga

Moderna Bolsters Its Pipeline With Two New mRNA-Based Vaccine Programs

Moderna Inc (NASDAQ:MRNA) expands its mRNA pipeline with two new development programs ahead of Annual Vaccines Day, building on Moderna's experience with Spikevax, its COVID-19 vaccine. The development programs include a combination respiratory vaccine candidate and a new program against all four endemic human coronaviruses (HCoV). First, Moderna is launching a respiratory combination…

Benzinga

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

Calliditas Therapeutics AB (NASDAQ:CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an…

Benzinga

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FDA Gives Green Signal For Palisade Bio's LB1148 Phase 3 Study

Palisade Bio Inc (NASDAQ: PALI) has

Benzinga

Time for an Operation Warp Speed to Develop Pan-Coronavirus Vaccines

Meanwhile the FDA dawdles over second boosters as new COVID-19 wave approaches

Reason

Pfizer CEO pushes yearly shots for COVID. Not so fast, experts say

When Pfizer CEO Albert Bourla said March 13 that all Americans would need a second booster shot, it struck many COVID-19 experts as a self-serving remark without scientific merit. It also set off spasms of doubt over the country’s objectives in its fight against the coronavirus.

Tribune News Service

FDA Approves Second Indication For Merck's Keytruda In Endometrial Cancer

The

Benzinga

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The Daily Biotech Pulse: Merck's Keytruda Snags Another FDA Approval, Pfizer Strikes COVID-19 Pill Supply Deal, Argenx Reports Positive Late-Stage Readout

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

Benzinga

75 Biggest Movers From Yesterday

Gainers NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) shares jumped 299.4% to close at $6.23 on Monday as the company received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects.

Benzinga

FDA To Hold Advisory Committee Meeting To Discuss COVID-19 Vaccine Future Boosters

The FDA that a panel of independent advisers will meet on April 6 to discuss considerations for using COVID-19 vaccine booster doses.

Benzinga

46 Stocks Moving In Monday's Mid-Day Session

Benzinga

NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC

NeuroSense Therapeutics Ltd (NASDAQ:NRSN) has received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects. PrimeC is a novel extended-release oral formulation composed of a fixed-dose combination of ciprofloxacin and celecoxib. PrimeC targets several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration,…

Benzinga

Certain type of Jergens moisturiser voluntarily recalled over possible bacteria contamination, FDA says

Recall applies to certain sizes of Jergens Ultra Healing Moisturiser

The Independent UK

Walmart and Kroger pancake mix recalled over ‘cable fragments’

Those who think they may have purchased two kinds of pancake and waffle mix are being asked to immediately throw them away

The Independent UK

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Tribune News Service

Conforme las píldoras abortivas aumentan, algunos estados se mueven para frenarlas

En junio, se espera que el Tribunal Supremo de Estados Unidos mitigue o derribe la decisión —Roe v. Wade— de casi 50 años de antigüedad que tiene sobre el derecho al aborto, dándole a los estados un amplio margen para restringir el procedimiento.

Benzinga

Here's Why Marinus Pharmaceuticals Shares Are Moving

Marinus Pharmaceuticals Inc (NASDAQ: MRNS) shares are trading higher by 25.0% at $10.72 after the company announced the FDA has approved ZTALMY oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder.

Benzinga

HC Wainwright Sees Almost 1000% Upside On Spectrum Pharma Stock

HC Wainwright reiterates the Buy rating on Spectrum Pharmaceuticals Inc (NASDAQ:SPPI), with a price target of $10. The analyst projects revenues of $170 million for Rolontis and $328 million for poziotinib in 2026. Eflapegrastim (formerly known as Rolontis; to be renamed) is a long-acting granulocyte colony-stimulating factor intended to stimulate neutrophil production for chemotherapy-induced neutropenia…

Benzinga

Sorrento's Pain Company Reveals Final Results For SP-102 Data For Sciatica Pain Management

Sorrento Therapeutics Inc's (NASDAQ: SRNE) subsidiary Scilex Holding Company has announced final results from its SP-102 Phase 3 Pivotal Trial C.L.E.A.R. Program. SP-102 (Semdexa) has received Fast Track status from the FDA.

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Benzinga

Kiora Pharma Snags Orphan Drug Tag For Inherited Genetic Eye Disease Candidate

The FDA has granted Orphan Drug designation to Kiora Pharmaceuticals Inc's (NASDAQ:KPRX) KIO-301 for Retinitis Pigmentosa. Retinitis Pigmentosa is an inherited genetic eye disease that can lead to severe vision loss due to rods and cones degeneration. Kiora expects to initiate clinical trials of KIO-301 in Q3 2022. The Company plans to begin a…

Benzinga

BTAI: Final Countdown to April 5, 2022 PDUFA Date for BXCL501…

By David Bautz, PhD NASDAQ:BTAI READ THE FULL BTAI RESEARCH REPORT

Benzinga

Zosano Lays Off ~30% Of Its Workforce After FDA Rejection Of Migraine Drug Application

Zosano Pharma Corp (NASDAQ: ZSAN) is looking at strategic alternatives and

The Independent UK

World Sleep Day: What an expert says about using melatonin to sleep

Melatonin is an over-the-counter sleep aid that’s loosely regulated by the FDA

Benzinga

Lexicon Announces Loan Facility Of $150M With Oxford Finance To Support Sotagliflozin Commercialization

Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) entered into a loan facility with Oxford Finance LLC for $150 million to support commercial preparations and the potential launch of sotagliflozin in heart failure. The loan facility consists of four tranches, each maturing in March 2027. An initial $25 million tranche was funded at closing. The second $25 million tranche…

Bangkok Post

B70m in fake cosmetic products seized

Police have seized about 70 million baht worth of fake cosmetic products bearing the names of 18 brands during a raid on a house in Bangkok’s Suan Luang district.

Benzinga

Like Pfizer, Moderna Seeks FDA Approval For Fourth COVID-19 Shot Or Second Booster Dose

Moderna Inc (NASDAQ: MRNA) has asked the FDA to authorize a

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