FDA Archives

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

News and Trends 19 Aug 2022

Axsome Therapeutics’ MDD treatment gets green light from FDA

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics, Inc.’s Auvelity tablets for the treatment of major depressive disorder (MDD) in adults. Auvelity (dextromethorphan HBr -bupropion HCl) is the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at […]

August 19, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 19 Aug 2022

Treatment for patients with fragile skin disease accepted by FDA

The U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for B-VEC, a treatment for patients with dystrophic epidermolysis bullosa (DEB). Krystal Biotech Inc. works in redosable gene therapy and made the announcement today (August 18). The application has been granted Priority Review designation, and the Prescription Drug […]

August 19, 2022 - 3 minutesmins - By Liza Laws

News and Trends 18 Aug 2022

FDA lifts partial clinical hold on Curis lymphoma study

Curis, Inc., a biotech company focused on the development of innovative therapeutics for the treatment of cancer, says the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim lymphoma phase 1/2 study of emavusertib after reviewing the data package submitted by Curis. “We are excited to announce that FDA […]

August 18, 2022 - 4 minutesmins - By Jim Cornall

beta-thalassemia blood APS antiphospholipid syndrome

News and Trends 18 Aug 2022

Patients with beta-thalassemia able to access first approved gene therapy

A gene therapy drug approved by the U.S. Food and Drug Administration (FDA) has been made accessible for people with beta-thalassemia. Zynteglo, a betibeglogene autoemcel, also known as beti-cel, treats adults and pediatric patients with the disease who need regular red blood (RBC) transfusions. The condition is passed down from one or both parents through […]

August 18, 2022 - 3 minutesmins - By Liza Laws

News and Trends 12 Aug 2022

Tetro Bio-Pharma enters subscription agreement following advice from Alpha Blue Ocean

Tetra Bio-Pharma Inc., a company working in cannabinoid-based drug discovery and development, has announced it has entered into a subscription agreement with investment vehicle Global Corporate Finance Opportunities 16 (GCFO 16). The announcement came yesterday (August 11) after Alpha Blue Ocean (ABO) advised the partnership whereby Canadian-based Tetra agrees to issue investor GCFO 16 senior […]

August 12, 2022 - 2 minutesmins - By Liza Laws

News and Trends 11 Aug 2022

First patient enrolled on Panbela’s trial for treatment of pancreatic cancer

Panbela Therapeutics, a U.S.-based clinical stage company, announced today (August 11) that it has enrolled its first patient in a global trial to evaluate a potential cure for pancreatic cancer. The trial referred to as ASPIRE will involve studying SBP-101, a treatment for metastatic pancreatic ductal adenocarcinoma. It is a randomized, double-blind placebo-controlled, trial with […]

August 11, 2022 - 3 minutesmins - By Liza Laws

News and Trends 9 Aug 2022

Mersana Therapeutics announces collaboration with GSK for the co-development of cancer treatment

A global collaboration was announced today (August 9) between Mersana Therapeutics Inc and GSK plc that will give GSK the option to co-develop and commercialize an antibody drug conjugate (ADC). The ADC called XMT-2056 is designed to activate the innate immune system through STING signaling in both tumor-resident immune cells and in tumor cells. Anna […]

August 9, 2022 - 3 minutesmins - By Liza Laws

News and Trends 8 Aug 2022

Positive trial results for schizophrenia drug, KarTX, from PureTech’s founded entity, Karuna Therapeutics

Positive topline results from a phase 3 trial looking at the effect of a drug to treat schizophrenia were announced today (August 8). Karuna Therapeutics Inc, the founded entity of PureTech Health plc, said results from the EMERGENT-2 trial evaluating the efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults met its primary endpoint and […]

August 8, 2022 - 4 minutesmins - By Liza Laws

News and Trends 8 Aug 2022

HUTCHMED drug in colorectal cancer trial meets primary endpoint

A trial to look at the use of a drug targeting refractory metastatic colorectal cancer (CRC) has met its primary endpoint of overall survival (OS) in patients with the disease. China’s HUTCHMED Limited announced today (August 8) that the phase 3 FRESCO-2 trial investigating the use of fruquintinib had met all secondary endpoints too. The […]

August 8, 2022 - 3 minutesmins - By Liza Laws

News and Trends 5 Aug 2022

Abivax has approval granted to enroll ulcerative colitis patients in two studies

Patients with moderate to severe ulcerative colitis (UC) can now be enrolled onto two phase 3 induction studies for a biotech company’s lead candidate drug. France-based Abivax SA is a phase 3 clinical stage biotech company that focuses on developing therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer. […]

August 5, 2022 - 3 minutesmins - By Liza Laws

News and Trends 4 Aug 2022

First of its kind drug, to reverse effects of cocaine intoxication, awarded grant

An enzyme that efficiently degrades and metabolizes cocaine has been given a ‘cooperative agreement grant’ from the National Institute on Drug Abuse (NIDA) part of the National Institutes of Health. The recombinant enzyme is a double-mutant cocaine esterase 200 mg intravenous (IV) solution and treats cocaine intoxication, which refers to the state of when cocaine […]

August 4, 2022 - 3 minutesmins - By Liza Laws

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FDA

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

Axsome Therapeutics’ MDD treatment gets green light from FDA

Treatment for patients with fragile skin disease accepted by FDA

FDA lifts partial clinical hold on Curis lymphoma study

Patients with beta-thalassemia able to access first approved gene therapy

Tetro Bio-Pharma enters subscription agreement following advice from Alpha Blue Ocean

First patient enrolled on Panbela’s trial for treatment of pancreatic cancer

Mersana Therapeutics announces collaboration with GSK for the co-development of cancer treatment

Positive trial results for schizophrenia drug, KarTX, from PureTech’s founded entity, Karuna Therapeutics

HUTCHMED drug in colorectal cancer trial meets primary endpoint

Abivax has approval granted to enroll ulcerative colitis patients in two studies

First of its kind drug, to reverse effects of cocaine intoxication, awarded grant

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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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