FDA Archives

News and Trends 11 Jan 2023

Renexxion goes to FDA with cystic fibrosis drug

Renexxion Ireland Limited has opened an investigational new drug (IND) application with the U.S Food and Drug Administration (FDA) for naronapride for the treatment of GI motility disorders in patients with cystic fibrosis (CF). This is a first step towards conducting clinical trials of the drug candidate in CF patients. Naronapride, post approval, could be […]

January 11, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 11 Jan 2023

AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma

Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra, (albuterol/budesonide, formerly known as PT027) is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication […]

January 11, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 9 Jan 2023

BD and CerTest Biotec receive emergency use authorization for mpox test

BD (Becton, Dickinson and Company), and CerTest Biotec have announced emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a molecular polymerase chain reaction (PCR) assay for mpox virus detection. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System is now available for BD MAX System users. “The […]

January 9, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 9 Jan 2023

Rani Therapeutics provides pipeline update

Rani Therapeutics Holdings, Inc. has completed a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) with respect to RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update. Following feedback from the meeting with […]

January 9, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 4 Jan 2023

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

Infex Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) designation to MET-X, the company’s broad spectrum metallo-beta-lactamase (MBL) inhibitor. Infex Therapeutics’ MET-X is a resistance bypass treatment that targets Gram-negative Enterobacterales. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics and evade antibiotic clearance of […]

January 4, 2023 - 2 minutesmins - By Jim Cornall

fungi fungal infections Scopulariopsis brevicaulis

News and Trends 20 Dec 2022

F2G looks for FDA new drug application approval for invasive fungal infections treatment

F2G Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its new drug application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options. F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal […]

December 20, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 14 Dec 2022

NMD Pharma cleared for spinal muscular atrophy trial

NMD Pharma A/S has received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to advance NMD670 into a phase II clinical study in patients of spinal muscular atrophy (SMA) type 3. NMD Pharma is a Danish clinical stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for […]

December 14, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 9 Dec 2022

Visiox Pharma announces FDA acceptance of glaucoma new drug application

Visiox Pharma, LLC has received notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its filing review and accepted for filing the New Drug Application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date […]

December 9, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 5 Dec 2022

Positive antibody persistence for vaccine treating mosquito disease

A single shot vaccine for mosquito-borne disease chikungunya has had positive antibody persistence data 12 months after vaccination. The primary endpoint also met with a 99% seroresponse rate. The disease is caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Following positive immunogenicity and safety data from a phase 3 study […]

December 5, 2022 - 3 minutesmins - By Liza Laws

Interview 5 Dec 2022

Interview: why the recently approved fecal microbiome product is causing a rumble

The news last week of the FDA approving Ferring Pharmaceuticals’ first fecal microbiome product, Rebyota, caused quite a stir in the field. The news was described as a huge step, a giant leap forward and simply fantastic. Paul Feurstadt is the director of non-inflammatory bowel disease research at the Medical Research Center of Connecticut. He also […]

December 5, 2022 - 5 minutesmins - By Liza Laws

News and Trends 2 Dec 2022

Tris Pharma and Pediatrix Therapeutics extend partnership for ADHD portfolio

Tris Pharma, Inc announced today (December 2) that they have expanded their partnership allowing Pediatrix Therapeutics to receive exclusive rights to commercialize its entire FDA-approved ADHD portfolio as well as ADHD pipeline products in China. Tris says it has a robust portfolio of FDA-approached products for the treatment of attention deficit/hyperactivity disorder (ADHD) and a pipeline of treatments […]

December 2, 2022 - 2 minutesmins - By Liza Laws

News and Trends 1 Dec 2022

FDA’s approval of first fecal microbiota product, Rebyota, hailed an ‘enormous step forward’ for the field

The first fecal microbiota product, Rebyota, approved by the U.S. Food and Drug Administration (FDA) today has been hailed ‘fantastic news’ by those in the microbiome field. Ferring Pharmaceutical’s product is approved to stop Clostridiodes difficile infection (CDI) in people over 18 and to be given after they have completed an antibiotic treatment for the […]

December 1, 2022 - 6 minutesmins - By Liza Laws

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FDA

Renexxion goes to FDA with cystic fibrosis drug

AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma

BD and CerTest Biotec receive emergency use authorization for mpox test

Rani Therapeutics provides pipeline update

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

F2G looks for FDA new drug application approval for invasive fungal infections treatment

NMD Pharma cleared for spinal muscular atrophy trial

Visiox Pharma announces FDA acceptance of glaucoma new drug application

Positive antibody persistence for vaccine treating mosquito disease

Interview: why the recently approved fecal microbiome product is causing a rumble

Tris Pharma and Pediatrix Therapeutics extend partnership for ADHD portfolio

FDA’s approval of first fecal microbiota product, Rebyota, hailed an ‘enormous step forward’ for the field

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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