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The Latest Breaking News from FDA

Welcome to the Nicotine Prohibition Era

Regulators have long targeted tobacco products, but there's new energy behind outright bans on vapes and cigarettes.

Reason

Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

Benzinga

The House Just Approved Marijuana Legalization Again, but GOP Support Remains Nearly Nonexistent

Just three Republicans voted for the MORE Act, two fewer than in 2020.

Reason

From analysis to the latest developments in health,
read the most diverse news in one place.

Mydecine Reports Financial Results For 2021

Late Thursday, Mydecine Innovations Group (OTC:MYCOF) reported financial results for the fiscal year ended December 31, 2021. 2021 Financial Results Net loss attributable to common stockholders was $28.9 million, which consisted of a $5.3 million loss from discontinued operations, for 2021, or a basic and diluted loss per share attributable…

Benzinga

T2 Biosystems Secures Additional BARDA Funding To Develop Blood Test Panels To Detect Sepsis-Causing Pathogens

The Biomedical Advanced Research and Development Authority (BARDA) is providing an additional $4.4 million in funding for the multiple-year cost-share contract between BARDA and T2 Biosystems Inc (NASDAQ:TTOO) If all contract options are exercised, the total potential BARDA funding is $69.0 million. The additional funding will be used to advance the U.S. clinical trials for…

Benzinga

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

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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

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

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

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news in one place.

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Los Angeles Times

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,…

Benzinga

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:

Get all your
news in one place.

100’s of premium titles.
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Benzinga

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

An advisory committee of the

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…

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…

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