FDA Archives

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

More News! 30 Nov 2022

FDA grants Sensorion Orphan Drug Designation for hearing loss drug

Sensorion a clinical-stage biotechnology company has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to OTOF-GT, its lead gene therapy program for hearing loss. The drug is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion is on track to file a clinical trial application (CTA) […]

November 30, 2022 - 3 minutesmins - By Liza Laws

News and Trends 24 Nov 2022

FDA gives IND approval for Ascletis Covid drug

Ascletis Pharma Inc. has revealed that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for Covid-19. The FDA has approved Ascletis to study the safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects […]

November 24, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 23 Nov 2022

FDA approves CSL gene therapy for hemophilia B

CSL has revealed that the U.S. Food and Drug Administration (FDA) has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or […]

November 23, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 21 Nov 2022

Legend Biotech small cell lung cancer drug gets FDA ok for clinical development

Legend Biotech Corporation has announced that the U.S. Food and Drug Administration (FDA) has cleared Legend Biotech’s investigational new drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC). LB2102 is […]

November 21, 2022 - 2 minutesmins - By Jim Cornall

More News! 18 Nov 2022

Triastek cleared for 3D printed medicine treatment of ulcerative colitis

Triastek, Inc. has received clearance for its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) to initiate clinical studies of the 3D printed medicine, T21, a potential treatment for ulcerative colitis. “We are excited to receive IND clearance to begin clinical trials of this potentially transformative treatment for patients,” […]

November 18, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 16 Nov 2022

Ascletis’ monkeypox tablet receives IND approval from the FDA

A drug to treat monkeypox from Ascletis Pharma has had its investigational new drug (IND) application approved by the U.S Food and Drug Administration (FDA). The FDA made its decision based on the available data, which was 800 mg ASC10 taken twice a day, and Ascletis can now go ahead with a phase 1b clinical […]

November 16, 2022 - 3 minutesmins - By Liza Laws

Ilya Pharma enrols first patient in diabetic foot ulcer study

More News! 15 Nov 2022

Destiny Pharma’s XF-73 dermal infection project advances to safety study

The second of two planned preclinical safety studies has started for Destiny Pharma’s XF-73 dermal formulation. The company announced the start of an investigational new drug (IND) today (November 15) and is developing the formulation for the prevention of infections associated with open wounds and broken skin including diabetic foot ulcers (DFUs). This second study […]

November 15, 2022 - 2 minutesmins - By Liza Laws

More News! 14 Nov 2022

BioSenic’s autoimmune disease platform adapting to meet unmet medical needs

BioSenic’s systemic autoimmune disease platform, originally designed by Medsenic, is now developing controlled dosages and new formulations adapted to a significant number of important indications with unmet medical needs. BioSenic specializes in serious autoimmune and inflammatory diseases as well as cell repair. The update follows the announcement of the merger between Bone Therapeutics and Medsenic […]

November 14, 2022 - 4 minutesmins - By Liza Laws

News and Trends 14 Nov 2022

New therapy transitions toxic immune cells from harmful to healing to fight effects of hyperinflammation in children

When we think about acute kidney injury (AKI) and multi-organ failure, we don’t often think about children. But approximately 4,000 pediatric patients in the U.S. each year have AKI requiring continual kidney replacement therapy (CKRT). These patient profiles are associated with long hospital stays, high morbidity and mortality (50%), and children who survive an AKI […]

November 14, 2022 - 5 minutesmins - By Jim Cornall

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FDA

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

FDA grants Sensorion Orphan Drug Designation for hearing loss drug

FDA gives IND approval for Ascletis Covid drug

FDA approves CSL gene therapy for hemophilia B

Legend Biotech small cell lung cancer drug gets FDA ok for clinical development

Triastek cleared for 3D printed medicine treatment of ulcerative colitis

Ascletis’ monkeypox tablet receives IND approval from the FDA

Destiny Pharma’s XF-73 dermal infection project advances to safety study

BioSenic’s autoimmune disease platform adapting to meet unmet medical needs

New therapy transitions toxic immune cells from harmful to healing to fight effects of hyperinflammation in children

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

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