FDA Archives

News and Trends 31 Jan 2023

Stargardt disease treatment gets FDA fast track

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) for MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to […]

January 31, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. The designation approval is based on results from the phase Ib clinical trial of TGCT cohort for Pimicotinib. […]

January 31, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

FDA clearance for ‘revolutionary’ approach to J-Pouch issue

ExeGi Pharma LLC, which develops live biotherapeutic drugs and probiotics, says the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. The clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or J-Pouch) who experience excessive stool frequency. “Excessive stool frequency […]

January 27, 2023 - 2 minutesmins - By Jim Cornall

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

Knowledge hub

Categories

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Approaches

Therapeutic areas

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

R&D

BD

World biotech leaders

Connect with decision-makers and researchers worldwide for collaborative opportunities

Company

Join Us

Subscribe to our newsletter

Advertise with us

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

FDA

Stargardt disease treatment gets FDA fast track

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

FDA clearance for ‘revolutionary’ approach to J-Pouch issue

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

Subscribe to our newsletter to get the latest biotech news!

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Subscribe to our newsletter

Get the latest biotech news directly to your inbox!

Newsletter Signup - Footer

Subscribe to our newsletter to get the latest biotech news!