New Drug Approvals

APRIL 18, 2025

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).

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New Drug Approvals

JUNE 26, 2025

Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. 284 (7): 4102–4111. 28 May 2025. Ma S, et al.

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Drug Target Review

MAY 1, 2024

To date, the 11 FDA-approved ADCs have shown benefit to patients across multiple solid and hematological malignancies with approvals in more than 20 indications. T-DM1, for example, is approved in patients with HER2-positive breast cancer and residual invasive cancer following neoadjuvant therapy.

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Drugs FDA Approval Organic Chemistry Small Molecule 69

The Pharma Data

NOVEMBER 8, 2021

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., 4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 versus 38.9%). .”

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The Pharma Data

MAY 7, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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The Pharma Data

JANUARY 31, 2021

Convergent has exclusive rights to technology related to next generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued U.S. The key component of Convergent’s PRRT prostate cancer therapy is its proprietary drug, CONV 01-?, If FDA approved, CONV 01-?

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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New Drug Approvals

DECEMBER 16, 2023

Retrieved 10 December 2023. ^ “Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH” Novartis (Press release). twitter +919321316780 call whatsaapp EMAIL. 5 December 2023. Retrieved 6 September 2023.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. Furthermore, the next-gen, combo therapies were generally well tolerated and served to improve sweat chloride levels.

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New Drug Approvals

APRIL 30, 2025

Jump up to: a b c d e f g h i j k l m n o “FDA Approves New Drug to Treat Niemann-Pick Disease, Type C” U.S. FDA Approval of Aqneursa for the Treatment of Niemann-Pick Disease Type C” IntraBio (Press release). New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA).

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The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

With PRISM, it’s now feasible to screen entire small molecule libraries across large panels of cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved.

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New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

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The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. Oral, Small Molecules.

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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).

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The Pharma Data

SEPTEMBER 8, 2020

In addition, over 170,000 people have been treated with OCREVUS, our first-in-class B-cell therapy, and we are incorporating years of clinical trial data and real-world evidence to optimise its potential to improve outcomes for patients with MS.”. Until the FDA approval of OCREVUS, there had been no FDA approved treatments for PPMS.

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The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

NOVEMBER 20, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

DECEMBER 11, 2020

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Source: Pfizer Inc. .

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The Pharma Data

NOVEMBER 9, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

FEBRUARY 4, 2021

AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

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Dark Matter Blog

AUGUST 27, 2020

A few years ago, at Arrakis Therapeutics, we set out to conquer a strange new territory, drugging RNA structures with small molecules. On the strength of those findings, nusinersen was approved by the FDA at the end of 2016 for the treatment of SMA , marketed under the commercial brand Spinraza. We will replace it.”

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Small Molecule RNA Clinical Trials Drugs 52

The Pharma Data

JANUARY 19, 2021

Precision medicine developer Kura Oncology is positioned to make a meaningful difference in the treatment of cancer in the next few years with its two, wholly-owned, small molecule compounds. As with any innovative therapy, “It takes multiple iterations and time to get things right,” he pointed out. “We Photo courtesy of Kura.

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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.

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The Pharma Data

OCTOBER 15, 2020

“Manufacturing cells is not like manufacturing small molecules,” Brian Culley, CEO of Lineage Cell Therapeutics , told BioSpace. For cell therapy products to mature into ‘real’ products that deliver on the promises of 10 years ago, they must be scalable – which drives affordability – and they must solve their purity issues.”.

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PerkinElmer

NOVEMBER 9, 2022

To date, the only FDA approved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs). Recent efforts have focused on the development of small-molecule inhibitors as an alternative approach to therapeutically target PD-1 or PD-L1.

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PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998.

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The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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The Pharma Data

FEBRUARY 25, 2022

CGRP Receptor Antagonism Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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Codon

APRIL 2, 2023

Read A one-time gene therapy injection for spinal muscular atrophy. Mice and human cells that were given the therapy had normal levels of the survival motor neuron protein, and no symptoms. Gene Therapy. Read A really simple way to isolate AAVs, which are a type of virus often used to deliver gene therapies into cells.

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The Pharma Data

DECEMBER 10, 2020

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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The Pharma Data

DECEMBER 21, 2020

Tagrisso was recently granted Breakthrough Therapy Designation for patients in the early-stage disease setting by the US FDA. At two years, 89% of patients treated with Tagrisso remained alive and disease free versus 52% on placebo after surgery, the current standard of care. J Clin Oncol. 2011:29;2121-27. Ellison G, et al.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757).

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New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. New Haven, CT. New Haven, CT. 2021 Jan 1;31:127624.

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The Pharma Data

JANUARY 6, 2021

“We are leveraging our strengths in process development and manufacturing for a wide range of biopharmaceuticals such as antibodies, recombinant proteins, gene therapies and vaccines,” said Martin Meeson , chief executive officer at FUJIFILM Diosynth Biotechnologies. Overview of New Site. 1.

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The Pharma Data

OCTOBER 28, 2020

Our R&D Engine continued to advance our Wave 1 pipeline, with 7 new regulatory filings anticipated within the next 12 months, and we expanded our cell therapy capabilities, both of which will help drive Takeda’s future growth. Press release ). Press release ). Press release ). Press release , website ).

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