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The Latest Breaking News from FDA

Dyne's Shares Gain After FDA Removed Clinical Hold On Muscular Disease Study

Dyne Therapeutics (NASDAQ: DYN) announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared its Investigational New Drug (IND) application to initiate a clinical trial of its drug DYNE-25.

Benzinga

What's Going On With Dyne Therapeutics Shares Today?

Dyne Therapeutics Inc (NASDAQ: DYN) shares are trading lower by 5.42% to $6.81 after the company announced FDA clearance of its Investigational New Drug application for DYNE-251 for the treatment of Duchenne muscular dystrophy.

Benzinga

Why IPO Stock Amylyx Pharmaceuticals Is Beginning To Heat Up — Again

IPO stock Amylyx Pharmaceuticals jumped Monday as the Food and Drug Administration prepares to review its controversial ALS treatment again.

Investors Business Daily

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Titan Pharmaceuticals Gets FDA Clearance To Commence Opioid Disorder Study

The U.S. Food and Drug Administration (FDA) has cleared Titan Pharmaceuticals’ (NASDAQ: TTNP) Investigational New Drug (IND) application for the Phase 1 study of its drug candidate Nalmefene.

Benzinga

Benzinga Pro's Top 5 Stocks To Watch For Tuesday, Jul. 5, 2022: RMED, RBCN, LEVI, DAL, TSM

Today's 5 Stock Ideas: Ra Medical Systems (RMED) - Shares up 55.5% premarket. The company announced it has received FDA 510(k) clearance for its DABRA 2.0 catheter. Rubicon Technology (RBCN) - Shares up

Benzinga

How Pfizer won the pandemic, reaping outsize profit and influence

The grinding two-plus years of the pandemic have yielded outsize benefits for one company — Pfizer — making it both highly influential and hugely profitable as COVID-19 continues to infect tens of thousands of people and kill hundreds each day.

Tribune News Service

40 tonnes of drugs to go up in smoke this week

The Food and Drug Administration (FDA) and narcotics suppression authorities on Monday inspected more than 40 tonnes of confiscated illegal drugs worth over 34.6 billion baht before they are incinerated at a designated facility this week.

Bangkok Post

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Parliament an unsafe workplace due to sexual misconduct by MPs, say unions

Political parties cannot be trusted to deal with misbehaviour by their own MPs, claim general secretaries

The Guardian - UK

The Sarepta Therapeutics Pipeline No One is Talking About

Gene therapy and gene editing get all the glory, but investors shouldn't overlook an emerging group of tools.

The Street

Medication abortion is common; here's how it works

Medication abortions were the preferred method for ending pregnancy in the U.S. even before the Supreme Court overturned Roe v. Wade

The Independent UK

News briefs

White House touts abortion pill as answer to Roe reversal but FDA rules limit use

Tribune News Service

HC Wainwright Finds 'Synergies In Treatment' For This Bipolar-Focused Stock

HC Wainwright initiated coverage on NRx Pharmaceuticals Inc (NASDAQ:NRXP) with a Buying rating and a price target of $2. Earlier today, the FDA declined to issue an Emergency Use Authorization for NRx's Zyesami for a subgroup of patients who also received Gilead Sciences Inc's (NASDAQ:GILD) remdesivir in addition to Zyesami. The analyst is bullish on: Significant potential for NRX-101 for…

Benzinga

US conservatives vow harsh restrictions to curtail abortion pills

Discreet and available by mail, abortion-inducing pills could make conservative abortion bans challenging to enforce.

Al Jazeera

Updating Coronavirus Vaccines Is Good, But a Universal Coronavirus Vaccine Would Be Better

Time for a new Operation Warp Speed?

Reason

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Benzinga

The Daily Biotech Pulse: FDA Wants Omicron-Targeted COVID-19 Boosters, Provention Bio Clears Hits Hurdle For Diabetes Prevention Drug, Oxford Biomedica, AstraZeneca Strike Vaccine Pact

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

Benzinga

FDA Turns Down NRx Pharmaceuticals' Emergency Use Submission For Covid-19 Candidate

The U.S.

Benzinga

FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants

The FDA's independent experts voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022. The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a…

Reason

Review: How Melatonin-Filled 'Lazy Cakes' Became the Subject of a Moral Panic

Senators asked for an investigation since the "sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin."

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Benzinga

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

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.

Tribune News Service

White House touts abortion pill as answer to Roe reversal but FDA rules limit use

The Biden administration says it’s taking steps to increase access to medication abortion in response to the Supreme Court decision to reverse Roe v. Wade, but some of the administration’s own policies stand in the way of people trying to get the drug.

Tribune News Service

Ask the Pediatrician: How do I know these unfamiliar brands of infant formula on store shelves are safe?

Q: Why am I seeing brands of baby formula I’ve never heard of, and are they safe?

The Conversation

The Supreme Court has curtailed EPA's power to regulate carbon pollution – and sent a warning to other regulators

In a highly anticipated but not unexpected 6-3 decision, the Supreme Court ruled on June 30, 2022, that the Obama administration’s Clean Power Plan exceeded the U.S. Environmental Protection Agency’s authority under the Clean Air Act.

Benzinga

New Restrictions On Synthetic Marijuana: Harm To The Cannabis Industry?

Beginning July 1, the Oregon Liquor and Cannabis Commission (OLCC) will be restricting the sale of some artificially derived synthetic cannabinoids in the state, reported the Oregonian.

The Street

Alnylam's 5th Drug Launches in July, Disrupting Commercial Landscape

A little competition can greatly benefit patients. Shareholders may have a more difficult path to navigate.

Benzinga

U.S. FDA Extends Review By Three Months For Provention Bio's Type 1 Diabetes Candidate

The U.S. Food and Drug Administration (FDA) has extended its review period by three months for Provention Bio’s (NASDAQ: PRVB) Biologics License Application (BLA) for teplizumab in patients with type 1 diabetes. The regulatory agency has set a new target action goal date of November 17, 2022.

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