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The Latest Breaking News from FDA

U.S. FDA Grants Orphan-Drug Designation for Allogene's ALLO-605 for multiple myeloma

Allogene Therapeutics, Inc. (Nasdaq: ALLO) received Orphan-drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its drug candidate ALLO-605 for the treatment of patients with multiple myeloma.

Benzinga · Apr 27, 2022

The Daily Biotech Pulse: Molecular Partners Plunges On Double Bad News, Pfizer/BioNTech Seek Nod For COVID-19 Shot In Kids, Pfizer Invests In Zentalis

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

Benzinga · Apr 27, 2022

U.S. FDA accepts Fennec Pharma's New Drug Application (NDA) Resubmission for PEDMARK

Fennec Pharmaceuticals Inc. (NASDAQ: FENC) announced that the U.S.

Benzinga · Apr 27, 2022

From analysis to the latest developments in health,
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Edwards Lifesciences Clocks 10% Top-Line Growth In Q1; Forecasts Lower Than Expected Q2 Sales

Edwards Lifesciences Corp (NYSE:EW) posted a Q1 adjusted EPS of $0.60, compared to $0.54 posted a year ago and beating the consensus of $0.57. Sales increased 10% to $1.34 billion (underlying 13%), beating the consensus of $1.31 billion. Transcatheter aortic valve replacement sales grew to $881 million, up 11%. Globally, the company's…

Benzinga · Apr 27, 2022

Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age. The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose…

Benzinga · Apr 27, 2022

Molecular Partners, Novartis Note EUA For COVID-19 Therapy May Need Additional Data

Molecular Partners AG (NASDAQ:MOLN) has provided an update regarding the Emergency Use Application (EUA) for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19. The Company says that EUA, in review with the FDA, may require additional clinical data to be authorized. Vas Narasimhan also noted that the current omicron wave of SARS-Cov-2,…

Benzinga · Apr 27, 2022

HIV PrEP is supposed to be covered, but often isn't

HIV prevention still comes with unexpected costs

Axios · Apr 27, 2022

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Benzinga · Apr 27, 2022

MMJ BioPharma Cultivation To Produce Quality Cannabis, Meeting DEA's Definition Of Chemical Reproducibility

MMJ BioPharma Cultivation, a cannabis company, received its DEA schedule 1 Analytical Lab Registration, which allows for the international importation of cannabis for research and development.

Benzinga · Apr 27, 2022

Another delay for five-and-under vaccine

The issue isn't around safety, but instead messaging and vaccine effectiveness

Salon · Apr 26, 2022

What's the difference between CBD & THC?

For starters, which one gets you high?

Salon · Apr 26, 2022

Pro-Patient Psychedelic Treatments Are Finally Moving Forward In A 'New Paradigm Shift'

Last week, Benzinga’s Psychedelics Capital Conference brought a premier gathering of the biggest publicly traded psychedelics companies in North America with forward-thinking investors to Miami, where the hottest topic seemed to revolve around LSD and derivative molecules.

Benzinga · Apr 26, 2022

Editas Medicine's EDIT-301 receives FDA Rare Pediatric Disease designation for Beta Thalassemia

The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia from leading genome editing company, Editas Medicine, Inc. (NASDAQ: EDIT).

Benzinga · Apr 26, 2022

Prothena Receives FDA Fast Track Designation for PRX012 for the Treatment of Alzheimer's Disease

Prothena Corporation plc (NASDAQ: PRTA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the anti-amyloid beta (Aβ) antibody therapy drug candidate PRX012 for the treatment of Alzheimer's disease.

Benzinga · Apr 26, 2022

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Benzinga · Apr 26, 2022

Gamida Cell Shares Jump On FDA Nod To Cell Therapy Trial In Blood Cancer Settings

The FDA has signed off and removed the clinical hold for a cryopreserved formulation of Gamida Cell Ltd's (NASDAQ:GMDA) GDA-201, an off-the-shelf cell therapy candidate for follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.…

Benzinga · Apr 26, 2022

U.S. FDA Grants Fast Track designation To Ofra-Vec (VB-111) For Platinum-Resistant Ovarian Cancer

VBL Therapeutics (NASDAQ: VBLT) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Ofra-Vec (VB-111) in combination with Paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.

Benzinga · Apr 26, 2022

The Daily Biotech Pulse: Protagonist's Ulcerative Colitis Study Disappoints, Gilead's Remdesivir Approved For Pediatric COVID-19 Patients, FDA Gives Nod To Gamida's Cell Therapy Trial, Fast Track Tag For Vascular Biogenics Ovarian Cancer Gene Therapy

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

Benzinga · Apr 26, 2022

Evoke Shares Skyrocket On New FDA Market Exclusivity For Gimoti Nasal Spray

The FDA has granted new drug product exclusivity to Evoke Pharma Inc's (NASDAQ:EVOK) Gimoti (metoclopramide) nasal spray to relieve symptoms associated with acute and recurrent diabetic gastroparesis in adults. Evoke now has exclusive marketing rights over three (3) years from the original date of approval under the Hatch-Waxman Act to protect the product from…

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The Conversation · Apr 26, 2022

The dietary supplement you're taking could be tainted with prescription medications and dangerous hidden ingredients, according to a new study

The Research Brief is a short take about interesting academic work.

Bangkok Post · Apr 26, 2022

Rush for weed licences ahead of narcotic delisting in June

Thailand’s Food and Drug Administration (FDA) has received some 4,700 applications for licences from people and organisations to import, possess, grow and produce cannabis and hemp.

Benzinga · Apr 26, 2022

Gilead's Remdesivir Becomes First Approved Treatment For Pediatric COVID-19 Patients

The FDA has approved Gilead Sciences Inc's (NASDAQ:GILD) supplemental marketing application for Veklury (remdesivir) for pediatric COVID-19 patients older than 28 days. The approval covers patients weighing at least 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe infection. This approval…

Benzinga · Apr 26, 2022

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The Guardian - US · Apr 26, 2022

Magically suspicious: why are thousands claiming sickness after eating Lucky Charms?

Reported symptoms include nausea, vomiting and diarrhea, but experts are raising questions about self-diagnosis

McClatchy Washington Bureau · Apr 26, 2022

1st COVID treatment for kids under 12 gets FDA approval. What to know about Veklury

The Food and Drug Administration approved Veklury — also known as the drug remdesivir — as the first COVID-19 treatment for children younger than 12 on Monday, April 25.

Benzinga · Apr 25, 2022

Psyched: Big Pharma's Sanofi Enters Psychedelics Space, DNA From 80 Psilocybe Mushrooms Published Online, Maine Psychedelics Bill Shelved

Benzinga’s first-ever Psychedelics Capital Conference was a colossal success. Over 600 investors, policymakers, industry executives and thought leaders gathered at the Fontainebleau Hotel in Miami Beach for a full day of networking and education.

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