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The Latest Breaking News from FDA

Checks and Balances: SEC publishes proposed climate disclosures rule

The Checks and Balances Letter delivers news and information from Ballotpedia’s Administrative State Project, including pivotal actions at the federal and state levels related to the separation of powers, due process, and the rule of law.

Ballotpedia

Oaktree, Qatar Investment Inject $260M In BioXcel To Fund Commercialization Of Schizophrenia Med

BioXcel Therapeutics Inc (NASDAQ:BTAI) received strategic financing from Oaktree Capital Management and Qatar Investment Authority (QIA) for gross funding of $260 million. The Company will use the funding to support the commercial activities of Igalmi (dexmedetomidine) sublingual film indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.…

Benzinga

Civil service unions condemn Rees-Mogg’s ‘vindictive’ back-to-office drive

Bosses of FDA and PCS criticise attempt by efficiency minister to name and shame departments with more remote workers

The Guardian - UK

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Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting. The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy. The application has also been…

Benzinga

Needham Estimates PhaseBio Pharma's Bentracimab Market Opportunity Of Up To $1.5B

PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS) remains on track to complete the bentracimab biologics license application (BLA) filing around mid-2022 for bleeding risks associated with using ticagrelor antiplatelet drug.

Benzinga

Despite Price Cut, HC Wainwright Keeps Buy Rating On TG Therapeutics - Read Why

TG Therapeutics Inc's (NASDAQ:TGTX) shares are plunging after new data showed that ublituximab /Ukoniq showed an elevated risk of death in the phase 3 Unity combo trial for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) HC Wainwright has slashed the price target from $68 to $19, with the Buy rating unchanged.…

Benzinga

Kaival Brands Expands Bidi Vapor Distribution

Kaival Brands Innovations Group Inc (NASDAQ:KAVL) has expanded its wholesaler and retailer distribution accounts for Bidi Vapor LLC, which are expected to reach 28,000 additional stores. "We anticipate the activation of approximately 3,900 new store locations over the next 45 days, including one new major retailer having already placed orders totaling more than $1.1 million," said…

Benzinga

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FDA Investigating Reported Illnesses Tied To Lucky Charms Cereal

Scores of consumers weren’t feeling very lucky after eating General Mills’ (NYSE: GIS) Lucky Charms cereal, with multiple reports of illness occurring after having a bowl of the longtime breakfast staple.

Benzinga

Japan's Health Ministry Panel OKs Approval Of Novavax's COVID-19 Vaccine: Report

Japan's health ministry panel authorized a plan to approve Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine, which is set to be the fourth such vaccine to be approved in Japan. It will be available for first and second shots with an interval of three weeks. The Novavax product is a recombinant protein vaccine that uses…

Benzinga

Why Ocugen Shares Are Trading Higher Today

Ocugen Inc (NASDAQ:OCGN) and Bharat Biotech have amended their co-development, supply, and commercialization agreement to expand Ocugen's exclusive territory to include the commercialization of Covaxin in Mexico. This gives Ocugen Covaxin commercialization rights for all of North America. Covaxin can be an ideal vaccination option for Mexico at this pandemic stage. As a whole…

Benzinga

Americans over 60 should get a second Covid vaccine booster, says White House official

Dr Ashish Jha said there was now ‘pretty compelling’ evidence that a second round of coronavirus booster vaccines would help protect older people

The Independent UK

California Democrats are delaying their vaccine plans. Here's why

SACRAMENTO, Calif. — California Democrats were moving toward requiring COVID-19 vaccines for students and keeping them from opting out of shots with personal belief exemptions.

Tribune News Service

FDA investigating Lucky Charms after reports of illness

The U.S. Food and Drug Administration is investigating Lucky Charms cereal after dozens of consumers complained of illness after eating it

The Independent UK

FDA authorises 1st breath test for COVID-19 infection

InspectIR COVID-19 Breathalyzer can give results in less than three minutes

The Hindu

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Reason

New Investigation Finds FDA's Food Side Is 'Broken'

Among experts on food safety, the consensus is that the FDA's food division isn't functional.

Tribune News Service

Noah Feldman: Will federal courts let states ban the abortion pill?

Even before the Supreme Court reverses Roe v. Wade, as most court watchers expect it to do this June, the legal battle about the aftermath of the decision is getting underway. By far the most consequential aspect of the fight is likely to be about state attempts to regulate medical…

Dynamite News

COVID-19: First breathing test for detecting Coronavirus is authorized by FDA

The Food and Drug Administration (FDA) authorized the first test, InspectIR COVID-19 Breathalyzer, to detect COVID-19 through the breath for emergency use. Full story on Dynamite News:

Mic

The FDA just approved a very quick, very accurate COVID breathalyzer test

Good riddance, brain-poking swabs.

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Salon

New state laws restrict abortion pills

Doctors abilities to consult patients on abortions is being further restricted by new legislation

Salon

When mice vape, flavor matters

Curiously, different JUUL flavors seemed to have different (negative) effects on mice in a novel e-cigarette study

Tribune News Service

First COVID breath test authorized by FDA

It’s a breath of fresh air.

The Independent UK

FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples

The Independent UK

FDA approves Covid breathalyzer that can detect cases in three minutes

Device can only be operated by trained professionals

The Times of India

Covaxin’s Phase 2/3 clinical trials put on hold in the US

HYDERABAD: The US Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s Covid-19 vaccine Covaxin in the US.

The Independent UK

Baby formula shortage: What is causing supply issue and which stores are rationing products?

Out-of-stock per centages reached higher than 40 per cent in seven states in first week of April

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