Alta Sciences

APRIL 17, 2024

According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. According to an article published in Frontiers in Pharmacology , as of October 2023, there were 15 FDA-approved ADCs on the market, and more than one hundred in clinical development in the U.S.A.,

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] July 2022). 1] It is taken by mouth. [1] 401 (10383): 1159–1171.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

Drug Target Review

SEPTEMBER 19, 2023

In spite of current success and possibility to be a successful cell technology model, the integration of organ-on-chips into drug development process needs more optimisation to be validated for FDA approval.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments. billion, compared with retail sales of $0.5

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

APRIL 8, 2021

We expect data from the studies in 2022. Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. from 2021 to 2022, up to $625 million. Ricciardi M.J. Press release.

DNA 52

DNA RNA Engineering Licensing 52

FDA Law Blog: Biosimilars

MAY 21, 2024

Even though President Joe Biden had asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” in October 2022 , we also wondered how the Department of Justice (“DOJ”) and DEA would receive the HHS recommendation. Basis at 24.

Regulations 69

Regulations FDA Drugs Treatment 69

Metabolite Tales Blog

JANUARY 22, 2025

Metabolism of 2024 FDA approved small molecules part 1 By Julia Shanu-Wilson Involvement of active metabolites The number of small molecules approved by the FDA in 2024 totaled 31 out of 50 NMEs with 56% (28) of these comprising small molecule therapies. Clin Pharmacokinet. What’s next? 2015 May;54(5):457-71.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

New Drug Approvals

APRIL 2, 2025

. ^ Jump up to: a b c [link] ^ “Alpha Cognition’s Oral Therapy Zunveyl Receives FDA Approval to Treat Alzheimer’s Disease” (Press release). World Health Organization (2022). Alpha Cognition. 29 July 2024. Archived from the original on 4 August 2024. Retrieved 4 August 2024 via Business Wire. 2015.12.003.

FDA 57

FDA FDA Approval Treatment Disease 57

Codon

FEBRUARY 23, 2025

Because of PEPFAR’s effectiveness, the United Nations (UN) set an ambitious goal in 2022 to end HIV transmission and eliminate AIDS-related deaths by 2030. 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.

Clinical Trials 67

Clinical Trials Virus Vaccine DNA 67