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Strata Oncology Unveils Strata PATH Trial contractpharma
March 03, 2021
The new platform clinical trial will evaluate FDA-approved therapies in novel biomarker profiles learned from real-world data.
Veru to progress Covid-19 drug into Phase III study pharmaceutical-technology
March 03, 2021
Veru is set to advance its drug VERU-111 into a Phase III registration clinical study on hospitalised high-risk Covid-19 patients for obtaining clinically meaningful benefits in the Phase II clinical trial.
FDA approves Nulibry to treat Molybdenum Cofactor Deficiency Type A pharmatimes
March 02, 2021
The US Food and Drug Administration (FDA) has approved BridgeBio Pharma and Origin Biosciences’ Nulibry (fosdenopterin), making it the first treatment to be authorised to reduce the risk of mortality in patients with molybdenum cofactor deficiency ...
HUMIRA Receives FDA Approval to Treat Pediatric Patients with Ulcerative Colitis americanpharmaceuticalreview
March 02, 2021
AbbVie announced the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine americanpharmaceuticalreview
March 02, 2021
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Sinopharm seeks EUA for Covid-19 vaccines in Philippines pharmaceutical-technology
March 02, 2021
Chinese company Sinopharm has submitted an application to the Food and Drug Administration (FDA) of the Philippines for emergency use authorization (EUA) of its Covid-19 vaccines.
FDA authorises emergency use of Janssen’s single shot Covid-19 vaccine pharmaceutical-technology
March 02, 2021
The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s single-dose Covid-19 vaccine.
Treatment for rare Duchenne muscular dystrophy mutation approved by FDA europeanpharmaceuticalreview
March 01, 2021
The FDA conditionally approved Sarepta’s Amondys 45 (casimersen) after interim Phase III results indicated the treatment is reasonably likely to be of clinical benefit.
Elicio Announces IND for Vaccine Targeting Mutated KRAS Cancers americanpharmaceuticalreview
March 01, 2021
Elicio Therapeutics has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for ELI-002. ELI-002 is an Amphiphile (AMP) KRAS therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG ...
Kura Oncology Receives FDA Breakthrough Therapy Designation for Tipifarnib americanpharmaceuticalreview
March 01, 2021
Kura Oncology announced its investigational drug, tipifarnib, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent or metastatic HRAS mutant head and ...

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