The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Approval was granted to Myovant Sciences. Professional. MONDAY, Dec.

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. This was the first-ever, pre-approval implementation science study developed to evaluate ways to integrate Cabenuva into U.S.

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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.

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The Pharma Data

MAY 17, 2021

In fact, in recent times, tens of billions of dollars have flooded into the Midwest to accelerate life sciences innovation, and Illinois is ranked in the top 10 states in funding from the US National Institutes of Health. They provide a deep dive into the windy city’s standing in the life science space. Tune in to hear more.

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The Pharma Data

AUGUST 27, 2020

The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. 22, 2020– Gilead Sciences, Inc. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. About Gilead Sciences. Gilead Sciences, Inc.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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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.

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The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. About Gilead Sciences. Gilead Sciences, Inc.

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The Pharma Data

NOVEMBER 15, 2020

In a deal set to be finalized early in 2021, Urovant Sciences has agreed to be fully acquired by largest investor and close partner, Sumitovant Biopharma. Vibegron also showed favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. .

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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. Fill out the form to read the full article.

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The Pharma Data

AUGUST 11, 2020

Photo by FDA/CDC. Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients. It has not received general approval to treat the virus in the US, but has in several European countries and Japan. The drug would go under the brand name of Veklury.

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Broad Institute

JULY 17, 2024

Drug toxicity can be an issue even after FDA approval; drug-induced cardiotoxicity (DICT) and drug-induced liver injury (DILI) each contribute to a significant percentage of post-market drug withdrawals. Seal began this work after wondering if more toxicology insights could be gleaned from a drug candidate’s chemical structure.

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. The comprehensive agenda for the symposium can be accessed in its entirety here.

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Drug Target Review

MARCH 12, 2024

Scientists from the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego have discovered thousands of bile acids. The study’s findings offer new insights into the biochemical language microbes use to influence distant organ systems, which could revolutionise the way researchers approach disease.

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The Pharma Data

JANUARY 6, 2021

SK Chemicals is a leading company in the fields of chemistry and life science. Since the establishment of Sunkyung Textiles in 1969, SK chemicals has grown through continuous change and innovation into a chemical and life sciences enterprise representing South Korea.

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Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval. Spanogle, Ph.D.

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The Pharma Data

OCTOBER 29, 2020

NASDAQ: REGN ) today announced that the company was once again ranked as the top company to work for by Science magazine in its annual Top Employers Survey of the global biotech and pharmaceutical industry. The rankings are available in the print issue of Science and at [link]. . Regeneron Pharmaceuticals, Inc. Schleifer , M.D.,

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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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. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Learn more now: www.cobas68008800.com.

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The Pharma Data

JULY 29, 2021

“This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX ® in upper limb spasticity treatment. BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. About BOTOX ®.

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KIF1A

JULY 1, 2023

In science, aligning mathematical models with experimental observations improves our understanding of the underlying biology. Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning. What’s a pre-print?

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The Pharma Data

OCTOBER 30, 2020

Regeneron (NASDAQ: REGN) is a leading science and technology company delivering life-transforming. FDA-approved medicines are only the beginning of our long-term commitment to solve the human body’s. medicines for serious diseases. impact on patient health. most complex mysteries.

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Drug Target Review

MAY 15, 2024

3 The value required is more than just a greater number of FDA approvals, it is also about completing milestones with limited capital – ie, biotech survival. The latter group (ie, most of us) are waiting for wet lab validation, market demonstration (FDA approvals), and a few other things (which we often cannot define).

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The Pharma Data

JANUARY 6, 2021

(“CytoDel” or “the Company”), a privately-held corporation, today announces the publication of preclinical data on the Company’s lead product, Cyto-111, in the peer-reviewed journal, Science Translational Medicine. Südhof, M.D.,

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The Pharma Data

OCTOBER 25, 2020

The company is developing its Tria valve technology in partnership with Caltech and CSIRO, Australia’s science agency. View source version on businesswire.com: [link]. Source link.

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Drug Target Review

MAY 27, 2024

Caris Life Sciences® (Caris) has been at the forefront of precision medicine. Caris Discovery, the therapeutic research arm of Caris Life Sciences, was launched to address the paucity of novel oncology drug targets and is uniquely poised to discover first-in-class ADC targets. Examples include HER2-low and FOLR1.

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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. Closing remarks Solution based science, but not problem-based science becomes the basis of success of science.

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The Pharma Data

MAY 7, 2021

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.

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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. Source link: [link].

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The Pharma Data

DECEMBER 16, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

SEPTEMBER 29, 2020

The therapy was approved in two formulations: a tablet and oral solution to treat those over two years old. The approval is the first treatment that uses a Janus kinase (JAK) inhibitor to be available in the US for the treatment of pcJIA. Xeljanz has already been approved in the US for multiple conditions associated with arthritis.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

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The Pharma Data

JANUARY 19, 2021

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

NOVEMBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

OCTOBER 27, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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