New Drug Approvals

MAY 9, 2025

2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1]

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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

SEPTEMBER 28, 2020

Nucala was first approved in 2015 to treat severe eosinophilic asthma as an add-on maintenance therapy for the condition, and for the treatment of eosinophilic granulomatosis with polyangiitis. It also received approval in 2019 to treat severe eosinophilic asthma in children. .

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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.

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The Pharma Data

AUGUST 20, 2020

The approval follows just one month after Mylan triumphed in the US District Court for the Northern District of West Virginia to invalidated Biogen’s patent on Tecfidera, though the company is appealing the decision. billion for Biogen through 2019. The drug generated $3.79 Matt Fellows. Source link.

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The Pharma Data

OCTOBER 31, 2020

With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. billion USD in 2019 and is estimated to reach 5.03 in the near future.” ” According to Global Data, the global market for influenza antivirals reached 2.34 billion USD by 2026 at a CAGR of 11.5%.

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New Drug Approvals

APRIL 25, 2025

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] 20 May 2019.

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The Pharma Data

DECEMBER 9, 2020

.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. Gifford, R.

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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. The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He was awarded with the Ignite Award at SLAS 2019. Georges has been an active member of the SLAS’ entrepreneurship and innovation scenes.

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New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] World Health Organization (2019).

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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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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He was awarded with the Ignite Award at SLAS 2019. Georges has been an active member of the SLAS’ entrepreneurship and innovation scenes.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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Broad Institute

JULY 19, 2023

Related news How one lab uses machine learning to solve a key gene therapy problem In 2019, Deverman’s group identified the protein that serves as a receptor for AAV-PHP.B, a capsid that is efficiently transported across the blood-brain barrier.

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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. 9, 2020 ).

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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. in January 2019 and is similar to EYSUVIS except at a higher 1% concentration of LE for post-surgery, versus.25%

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

To that end, below is a list of the cases Vanda has filed over the past five years or so against FDA or another government agency or entity, as well as a list of FDA Citizen Petitions and appeals. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA signatory authority on Tradipitant NDA action Memorandum Opinion (D.D.C.)

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The Connected Lab

APRIL 8, 2020

For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3. Billion; Approval Rate for Drugs Entering Clinical Development Is Less Than 12%.” Nature , vol.

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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. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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The Pharma Data

AUGUST 20, 2020

Through a collaboration first signed in 2012, the two companies in 2017 successfully won FDA clearance for the first digital pill, Abilify MyCite, an ingestible drug-device combination that can track whether a patient adheres to the Japanese drugmaker’s antipsychotic Abilify (aripiprazole). One potential reason for the struggle?

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The Pharma Data

NOVEMBER 15, 2020

Federal Drug Administration (FDA) for vibegron in December 2019 after reporting positive data from its 12-week Phase III EMPOWUR study. Vibegron also showed favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. .

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. Before 1983, only 38 orphan drugs had received U.S.

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New Drug Approvals

SEPTEMBER 20, 2023

Jump up to: a b “Aphexda approval letter” (PDF). World Health Organization (2019). Motixafortide 4F-benzoyl-TN-14003 BKT-140 BKT140 BL-8040 Protein Chemical FormulaC 97 H 144 FN 33 O 19 S 2 Protein Average Weight2159.6 8 September 2023. Archived from the original (PDF) on 14 September 2023. BioLineRx Ltd. 11 September 2023.

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PerkinElmer

JANUARY 7, 2022

Sci Rep 9, 18911 (2019). link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet]. References Hingorani, A.D., Improving the odds of drug development success through human genomics: modelling study. 2021 [cited 16 December 2021].

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New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). 24 August 2022. AOP Health.

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The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). million for the quarter ended September 30, 2019 (the “2019 Quarter”) and $33.6

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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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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). Strupp M, Bayer O, Feil K, Straube A (February 2019). 24 September 2024. N Engl J Med.

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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] June 2019). 1] It is taken by mouth. [1] 20 (4): 413–420. 2017.03.007.

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The Pharma Data

NOVEMBER 8, 2021

4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6 About Aimovig® (erenumab-aooe) Aimovig is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.6

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The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders.

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The Pharma Data

SEPTEMBER 8, 2020

Roche is therefore initiating two new Phase IIIb trials, one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE), which will evaluate a higher OCREVUS dose compared with the currently approved 600 mg dose, with both evaluated at the twice-yearly (six-monthly) dosing schedule. In 2019, Roche invested CHF 11.7

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Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression. Its use in the treatment of substance use disorders is still under study. Asia, and Europe.

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The Pharma Data

SEPTEMBER 10, 2020

Until the FDA approval of OCREVUS, there had been no FDA approved treatments for PPMS. About OCREVUS® (ocrelizumab) OCREVUS is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS, in addition to CIS in the U.S.)

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The Pharma Data

JANUARY 7, 2021

Securities and Exchange Commission (the “SEC”) on September 27, 2019 and declared effective on October 24, 2019, and the accompanying prospectus contained therein. The securities described above are being offered by Cerecor pursuant to an effective shelf registration statement on Form S-3 (File No. Forward-Looking Statements.

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The Pharma Data

OCTOBER 21, 2020

While the majority of participants (93%, 1,615) maintained their routine dosing schedule from December 2019 through the analysis end point of September 15, 2020, 129 participants (7%) in the ongoing clinical trials had a planned injection visit that was impacted by COVID-19. Source: GSK . Posted: October 2020. Source link.

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