New Drug Approvals

JULY 8, 2025

7] If the virus also acquires resistance to foscarnet, then there is currently no FDA approved treatment. 2018 Oct 23;9:2483. 2018 Jan;149:1-6. The use of foscarnet is commonly accompanied by restrictive toxicity, particularly nephrotoxicity. [7] Bibcode : 1989PNAS…86.2186C. doi : 10.1073/pnas.86.7.2186. PMC 286876.

Virus

BioPharma Drive: Drug Pricing

JANUARY 2, 2025

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.

FDA Approval

Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

FDA Approval

Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. Sugano, 2018. References Iversen et al.,

Small Molecule

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. link] [2] Zhang and Tang, 2018. 2018 Sep;8(5):721-732. Br J Pharmacol.

Small Molecule

The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

FDA Approval

PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. This DNA Science post from 2018 traces the history of the efforts.

FDA Approval

Advarra

JULY 26, 2022

The 2018 Farm Bill. The 2018 Farm Bill removed hemp from the Controlled Substance Act. Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

Regulations

The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

FDA Approval

Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [10] FDA prescribing information for gepirone. Health Sci Rep. 6(10):e1610.

Small Molecule

The Pharma Data

JANUARY 6, 2021

2018)2: Menter MA, Armstrong AW, Gordon KB, Wu JJ. 2018 Feb;37(2S):S48-S51. UNION is headquartered in Hellerup ( Denmark ) and is managed by an experienced international team. For more information please visit: www.uniontherapeutics.com. Sources 1: Li et al. Common and Not-So-Common Comorbidities of Psoriasis. Semin Cutan Med Surg.

FDA Approval

The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test.

FDA Approval

The Pharma Data

MAY 31, 2022

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Food and Drug Administration in 2017.

FDA Approval

The Pharma Data

NOVEMBER 2, 2020

If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. In 2018, the FDA approved Epidiolex as a treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. It also forced the U.S.

FDA Approval

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. .

Treatment

The Pharma Data

JANUARY 18, 2021

Given the pandemic, 2020 can’t be viewed as a typical year, but Prevision noted that the number of applications for new drugs or indications sent to the committees had already decreased steadily pre-pandemic, with only 23 in 2019 and 30 in 2018.

FDA

New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

FDA Approval

Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. There are two things of note from this year.

FDA

New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).

FDA Approval

Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

Therapies

The Pharma Data

JUNE 17, 2022

This potential approval of Hyrimoz HCF builds on the already approved and well-established Sandoz biosimilar portfolio in immunology, including Erelzi ® (biosimilar etanercept), Zessly ® (biosimilar infliximab) and Rixathon ® (biosimilar rituximab, including rheumatoid arthritis indication).

Biosimilars

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. 2018) , Arnold Partnership v. Another case of same-day (and same-time) FDA approvals!

FDA Approval

New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] Food and Drug Administration (FDA) (Press release). 14 August 2024.

FDA

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 In 2018, Janssen Biotech, Inc.

Treatment

FDA Law Blog: Biosimilars

AUGUST 12, 2024

Since 1991, FDA has taken the position that the testing phase starts when the sponsor submits a request to Center for Veterinary Medicine to establish an INAD file and ends when an NADA is submitted. Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014.

FDA

Eye on FDA

JANUARY 16, 2023

Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. Looking at the second chart below, one can see that the number of AdComms since 2018 peaked in the same year FDA approved a record number of new molecular entities (NMEs).

FDA

New Drug Approvals

AUGUST 26, 2023

Zuranolone CAS 1632051-40-1 Zurzuvae FDA APPROVED 8/4/2023, To treat postpartum depression Press Release WeightAverage: 409.574 Monoisotopic: 409.272927379Chemical FormulaC 25 H 35 N 3 O 2 SAGE 217 SAGE-217 SAGE217 Zuranolone , sold under the brand name Zurzuvae , is a medication used for the treatment of postpartum depression. [1]

FDA

Practical Cheminformatics

FEBRUARY 1, 2023

The 2018 paper by Gómez-Bombarelli, which launched the field, has already been cited more than 2,100 times. As of 2021, there are over 70 FDA-approved drugs that are kinase inhibitors. Some examples of FDA-approved kinase inhibitors include imatinib (Gleevec), dasatinib (Sprycel), and lapatinib (Tykerb).

FDA Approval

Drug Target Review

JULY 5, 2024

Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 15(9):700-706 (2018) [link] Deshmukh V, et al. 12(3) (2023). link] Madhavan M, et al. Nat Methods. 502:327-332 (2013).

Drugs

The Pharma Data

JANUARY 31, 2021

The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018 , following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Clinical Trials

The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Department of Health and Human Services FDA Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.

Doctors

Drug Target Review

AUGUST 3, 2023

An analysis of all terminated trials within the Clinical Trials Database by GlobalData in 2018 found the single highest reason for trial termination – at 55 percent of total trials – was a low enrolment rate. And precision medicine studies suffer from challenges common to all clinical trials, such as poor enrolment and retention rates.

DNA

The Pharma Data

MARCH 30, 2021

The results were announced in a June 2018 press release and were also presented at the 2019 American Headache Society Annual Meeting.

Treatment

The Pharma Data

DECEMBER 3, 2020

The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Vaccine

Agency IQ

APRIL 26, 2024

In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. However, the 2018 guidance it did not offer advice for interchangeable product labeling. The FDA published recommendations for interchangeable products separately in a completely new guidance , issued two years later.

Biosimilars

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials

The Pharma Data

JUNE 28, 2021

” Aimovig (erenumab-aooe) was approved as a preventive treatment for migraine in adults in the United States on May 17, 2018. As of May 2021, it has been approved in 71 countries or territories, including the European Union, the United Kingdom, Canada, and Australia, and is approved by many regulatory authorities worldwide.

Treatment