Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

Disease 111

Disease Clinical Trials Therapies Science 111

The Pharma Data

NOVEMBER 10, 2020

SAMI is a renal replacement therapy (RRT) machine manufactured and commercialized by Spectral’s wholly-owned subsidiary, Dialco Medical Inc. ( “Dialco” ). The paper describes the first month of using SAMI as part of UMMC’s PIRRT (Prolonged Intermittent Renal Replacement Therapy) program throughout April 2020.

Therapies 52

Therapies FDA Nurses FDA Approval 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.

Licensing 40

Licensing Licensing Therapies Laboratories 40

PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. The original approved was in 2003 to treat a type of Gaucher disease. Until today, there were no approved therapies in the US.

Disease 52

Disease FDA Approval Drugs Treatment 52

The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

Clinical Trials 52

Clinical Trials DNA Trials Treatment 52

The Pharma Data

MARCH 4, 2021

Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. It is approved and commercially available as OLUMIANT in the U.S. associate professor of Dermatology at Yale School of Medicine.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

APRIL 8, 2021

“Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. It is approved and commercially available as OLUMIANT in the U.S. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.

Hospitals 52

Hospitals FDA Approval Laboratories Treatment 52

The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Test patients for latent TB before initiating Olumiant and during therapy. See the full Prescribing Information here.

Treatment 52

Treatment Clinical Trials Drugs Therapies 52

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. vice president of immunology development at Lilly.

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Therapies Treatment Disease Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is also approved for the treatment of certain hospitalized patients with COVID-19 in Japan. Serious Side Effects.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

The Pharma Data

MARCH 27, 2022

It is approved in the U.S. and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis and is approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Licensing 40

Licensing Licensing Disease FDA Approval 40

The Pharma Data

OCTOBER 14, 2020

is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). About ImmunityBio ImmunityBio, Inc.

Vaccine 40

Vaccine Trials FDA Clinical Trials 40

The Pharma Data

JULY 29, 2021

The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

Codon

MARCH 28, 2023

In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall. The first project, REMIND, began in 2009. View our database of DARPA neurotechnology projects online. “I am a brain, Watson.

Engineering 52

Engineering Research Science FDA Approval 52

Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. million by 2004.

Clinical Trials 67

Clinical Trials Virus Vaccine DNA 67

Drug & Device Law

SEPTEMBER 19, 2022

555 (2009) , and PLIVA, Inc. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. c)(6)(iii)(A).

Regulations 10

Regulations FDA Approval FDA Drugs 10