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The Latest Breaking News from FDA

FDA Pushes Merck's Pneumococcal Vaccine Decision Date Into July For Expanded Use In Kids

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental marketing application for Merck & Co Inc's (NYSE: MRK) pneumococcal 15-valent conjugate vaccine

Benzinga

The Daily Biotech Pulse: SELLA In-licenses Oncology Asset, Merck's Pneumococcal Vaccine Review Extended, Arc Biopharma COVID Drug Flunks Mid-Stage Study

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

Benzinga

Tomorrow's COVID safety guidelines will be different from today's – but that doesn't mean yesterday's were wrong

No one gave a second thought to the safety of dining out before the pandemic. Fast-forward to today, and it’s normal to wonder whether there is a city, state or federal policy around whether you need a mask or proof of vaccination to eat in a restaurant. The public policies…

The Conversation

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Beyond longevity: The DIY quest to cheat death and stop aging

Biohackers engage in DIY biology, experimenting on themselves to enhance their brain and body. And many of them see longevity as the ultimate prize.

Inverse

Commentary: FDA shouldn’t approve ALS drug without more data

A panel of the Food and Drug Administration’s expert advisers on Wednesday voted 6 to 4 against approving Amylyx Pharmaceuticals’ treatment for ALS. The FDA now has until June 29 to decide whether to follow the panel’s advice or let the closely watched drug on to the market.

Tribune News Service

FDA Approves Edwards Lifesciences' Resilia Valve For Mitral Replacement Surgery

The FDA has approved Edwards Lifesciences Corp's (NYSE: EW) Mitris Resilia valve, a tissue valve replacement specifically designed for the heart's mitral position.

Benzinga

Sorrento To Start Late-Stage Trial Of Abivertinib In Critically-Ill COVID-19 Patients

The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ:SRNE) Phase 3 trial of abivertinib in severe COVID-19 patients. The clinical trial will be conducted in 2 phases, and the initial run-in will define the recommended Phase 3 Dose. In October last year, Sorrento released preliminary results of two phase 2 studies that seemed to show…

Benzinga

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InflaRx Shares Plunge After Disappointing Results On Vilobelimab In Critically Ill COVID-19 Patients

InflaRx N.V. (NASDAQ:IFRX) announced topline data from Phase 3 part of Phase 2/3 PANAMO study of vilobelimab in critically ill COVID-19 patients. Vilobelimab in mechanically ventilated COVID-19 patients showed a relative reduction in 28-day all-cause mortality of 23.9% (vilobelimab 31.7% versus placebo 41.6%), which was not statistically significant (p=0.094). At the recommendation of…

Benzinga

Supply Chain Challenges To Hit Masimo's Q1 FY22 Sales

Masimo Corp (NASDAQ:MASI) expects Q1 FY22 product revenue of $285 million - $315 million, lower than expected. Shortages of critical components and other supply chain issues, including freight carrier delays, have led to lower-than-expected sales in the first quarter. Related: Joe Kiani, Chairman, and CEO, said, "In prior quarters, we were able…

Benzinga

Q&A: I’m eligible for a second COVID-19 booster shot. Should I get it?

So you took the first COVID-19 vaccine that was offered to you and — if it was one of the two mRNA vaccines available in the U.S. — you went back on schedule to get the second jab. When the Centers for Disease Control and Prevention recommended a booster shot,…

Los Angeles Times

FDA Warns CBD Companies To Stop Claiming Their Products Can Treat COVID-19

The FDA issued a letter warning seven CBD companies to re

Benzinga

Clovis Oncology's Rubraca Significantly Improves PFS In Ovarian Cancer Regardless Of Biomarker Status

Clovis Oncology Inc (NASDAQ:CLVS) announced positive topline data from the monotherapy arm of Phase 3 ATHENA-MONO trial of Rubraca (Rucaparib) as first-line maintenance treatment in ovarian cancer. Rubraca achieved the primary endpoint of significantly improved progression-free survival (PFS) compared with placebo (20.2 months vs. 9.2 months). The median PFS for the HRD-positive patient…

Benzinga

The Daily Biotech Pulse: Amylyx Announces Negative Adcom Vote, Clovis Jumps On Ovarian Cancer Data, Masimo Warns Of Q1 Shortfall

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

Benzinga

FDA Panel Votes Down On Amylyx's ALS Drug, Further Fading Its Hope For Regulatory Success

An advisory committee of the

Benzinga

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The Times of India

Pharmacy in hospital sealed for selling illegal drugs

CHANDIGARH: The food and drug administration department of the Haryana government on Wednesday raided and sealed a pharmacy counter inside a hospital in Faridabad for flouting norms .

Salon

FDA approves second shot for 50+

The authorization for another booster arrives just as BA.2 becomes the dominant strain in the U.S.

The Independent UK

FDA panel narrowly sides against experimental ALS drug

Federal health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease

Benzinga

FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's (NASDAQ:AKBA) marketing application (NDA) for vadadustat for anemia due to chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. The FDA issues a CRL to indicate that the review cycle for an application is complete…

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Benzinga

EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE:GSK) application seeking conditional authorization for their COVID-19 vaccine. The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be…

StockNews.com

5 Healthcare Stocks Likely to Withstand a Recession

The healthcare industry has attracted massive investor interest since the onset of the COVID-19 pandemic and could remain in the limelight as COVID cases surge again and necessitate the need for more COVID shots. In addition, the healthcare sector is known to withstand recessions relatively well. So, with several analysts…

Benzinga

Ketamine Wellness Centers Offering FDA Approved Esketamine Treatment For Major Depressive Disorder

Ketamine Wellness Centers subsidiary of Delic Holdings Corp (OTCQB: DELCF) (CSE:DELC) (FRA:6X0), has expanded its treatment options to include SPRAVATO nasal spray. The KWC clinics located in Houston, Las Vegas and Seattle will be offering this treatment option beginning April 1.

Benzinga

Adagio's COVID-19 Antibody Meets Primary Goals Across Pre & Post-Exposure Prophylaxis, Treatment

Adagio Therapeutics Inc's (NASDAQ:ADGI) Phase 2/3 trials evaluating 300 mg adintrevimab (ADG20) as pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19 have met its primary endpoints. Following the emergence of the omicron variant, a pre-specified exploratory analysis in a subset of the pre-exposure cohort, adintrevimab exhibited a clinically meaningful reduction in cases…

Benzinga

FDA Says Yes To Testing Receptor Life's Dry Power Inhaled CBD To Treat Social Anxiety Disorder

The FDA accepted Receptor Life Sciences’ investigational new drug application for RLS103. RLS103, a dry powder inhaled CBD, which is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder.

Inverse

Does creatine make you stronger? How the supplement may boost athleticism

Creatine is one of the most popular sport nutrition supplements, but does it work the way people want it to? Inverse spoke to creatine users and sports performance experts to find out.

Benzinga

Why BioNTech Shares Are Surging Today

BioNTech SE (NASDAQ:BNTX) reported Q4 FY21 revenues of €5.53 billion compared to €345.4 million a year ago, mainly due to high demand for the company's COVID-19 vaccine. BioNTech and its partner Pfizer Inc (NYSE:PFE) delivered approximately 2.6 billion doses of Comirnaty/BNT162b2 worldwide in 2021, including over 1 billion doses to low- and middle-income countries. As…

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