FDA Archives

News and Trends 8 Sep 2022

Integral Molecular joins FDA’s ISTAND program

Integral Molecular has been accepted into the U.S. Food & Drug Administration (FDA)’s ISTAND (Innovative Science and Technology Approaches for New Drugs) pilot program. The program supports, and was created to expand, the drug development tool types listed in the 21st Century Cures legislation. A major goal of the pilot program is to qualify these […]

September 8, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 5 Sep 2022

Avacta’s drug targeting soft tissue sarcoma granted Orphan Drug Designation by FDA

A drug to treat soft tissue sarcoma has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). Clinical stage oncology drug company Avacta Group plc has produced a form of the generic chemotherapy, doxorubicin AVA6000. About Avacta’s drug The drug has been modified using the company’s pre|CISION technology and Affirmer […]

September 5, 2022 - 2 minutesmins - By Liza Laws

News and Trends 2 Sep 2022

Psoriasis pustules disappear in over half of patients using Boehringer Ingelheim drug

More than half of patients treated for psoriasis with an intravenous injection showed no visible pustules just one week after receiving treatment. Boehringer Ingelheim announced today (September 2) that the U.S. Food and Drug Administration (FDA) has approved the first treatment option, SPEVIGO, for generalized pustular psoriasis (GPP) flares in adults. SPEVIGO is a novel, […]

September 2, 2022 - 2 minutesmins - By Liza Laws

News and Trends 1 Sep 2022

Study of injection to treat schizophrenia to begin after $3M payment received

A phase 3 clinical trial for an injection to treat patients with schizophrenia has been initiated after a $3 million payment was received by MedinCell. Teva Pharmaceuticals made the decision to start the trial for mdc-TJK this week (August 29). Schizophrenia is a serious mental disorder in which people interpret reality abnormally. Schizophrenia can produce a […]

September 1, 2022 - 2 minutesmins - By Liza Laws

News and Trends 1 Sep 2022

Sanofi’s first treatment in the U.S. approved for adults and children with ASMD

A rare, inherited disease that affects the body’s ability to metabolize fat, cholesterol and lipids within cells can now be treated by Xenpozyme, a drug approved by the U.S. Food and Drug Administration (FDA). Adults and children with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) can now take healthcare company Sanofi’s Xenpozyme […]

September 1, 2022 - 4 minutesmins - By Liza Laws

Futura medical erectile dysfunction medication

News and Trends 31 Aug 2022

Gel treatment for erectile dysfunction receives positive results from clinical trial

Futura Medical has announced positive results from a clinical trial looking into MED3000, a topical gel formulation for the treatment of erectile dysfunction (ED). The results, from the confirmatory phase 3 clinical study, FM71, were announced today (August 31). MED3000 is a breakthrough, fast-acting gel produced by Futura Medical’s transdermal DermaSys drug delivery technology. It […]

August 31, 2022 - 3 minutesmins - By Liza Laws

News and Trends 31 Aug 2022

United BioPharma gets FDA approval for phase 2 HIV drug trial

Taiwan-headquartered United BioPharma (UBP) says the U.S. Food and Drug Administration (FDA) has approved a phase 2 clinical trial IND submitted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of NIH. The purpose of the study is to assess the safety and antiviral activity of UB-421 in combination with optimized background ART […]

August 31, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 30 Aug 2022

Hemophilia drug from Sanofi and Sobi has license application accepted for priority review by FDA

The Biologics License Application (BLA) for Efanesoctocog alfa, a drug to treat the rare and life-threatening blood disease, hemophilia A, has been accepted for priority review by the U.S. Food and Drug Administration (FDA). Efanesoctocog alfa (BIVV001) is being developed and commercialized as part of a collaboration between Sanofi and Sobi was given the target […]

August 30, 2022 - 2 minutesmins - By Liza Laws

News and Trends 25 Aug 2022

Hope for children with chronic graft versus host disease as Johnson & Johnson drug approved

A treatment for chronic graft versus host disease in children aged one year and older has been approved by the U.S. Food and Drug Administration (FDA). Graft versus host disease is a common complication after receiving a donor stem-cell or bone marrow transplantation. Sometimes, the graft doesn’t recognize the host as being friendly and sees the […]

August 25, 2022 - 3 minutesmins - By Liza Laws

News and Trends 23 Aug 2022

Ocelot Bio receives FDA Orphan Drug Designation for lead candidate for treatment of hepatorenal syndrome

Ocelot Bio, Inc., a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of hepatorenal syndrome. Ocelot Bio is currently enrolling patients in a phase 2 clinical trial of OCE-205 in hepatorenal syndrome with acute kidney injury (HRS-AKI), […]

August 23, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 22 Aug 2022

Ascletis is first Chinese biotech company to get IND approvals for oral RdRp inhibitor

An investigational new drug (IND) application for a COVID-19 treatment has been approved by the China National Medical Products Administration (NMPA). The application is for ASC10, an oral inhibitor drug candidate targeting RNA-dependent RNA polymerase (RdRp) that targets the COVID-19 virus. China’s first Ascletis is China’s first biotech company to obtain IND approvals of an […]

August 22, 2022 - 2 minutesmins - By Liza Laws

News and Trends 22 Aug 2022

Santhera and ReveraGen announce first patient with Becker muscular dystrophy dosed in FDA-funded pilot study

The first patient has been dosed in a phase 2 pilot study looking at a treatment for muscular dystrophy. Santhera Pharmaceuticals and ReveraGen BioPharma made the announcement that vamorolone is to be assessed in patients with Becker muscular dystrophy (BMD). The study is being funded by the U.S. Food and Drug Administration (FDA). Eric Hoffman, […]

August 22, 2022 - 3 minutesmins - By Liza Laws

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