New Drug Approvals

MAY 8, 2025

Retrieved 22 November 2023. ^ “Jaypirca Product information” Union Register of medicinal products. Jump up to: a b c d e f “FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma” FDA. Food and Drug Administration (FDA). 20 November 2023. Eli Lilly.

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The Pharma Data

OCTOBER 21, 2020

a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. Additional information is available at www.nevakar.com.

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New Drug Approvals

MAY 9, 2025

2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Jump up to: a b c d e f g “FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. Food and Drug Administration (FDA). 8 February 2023. 27 January 2023.

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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] 3 November 2006. cd-21-0072.

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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. About Advanced Bionics.

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New Drug Approvals

JUNE 29, 2025

1] [2] Adverse effects The FDA prescribing information for taletrectinib includes warnings and precautions for hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. [1] Food and Drug Administration.

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The Pharma Data

DECEMBER 16, 2020

CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. For more information, please visit www.CNSPharma.com. Forward-Looking Statements .

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). For more information, please visit [link]. About Biohaven. About CGRP.

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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] 1] It is taken by mouth. [1] Hz, 1 H), 4.62−4.75

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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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New Drug Approvals

SEPTEMBER 8, 2024

Reproduction is authorized provided the source is acknowledged. ^ “Yorvipath Product information” Union Register of medicinal products. Jump up to: a b c d e f g h “FDA approves new drug for hypoparathyroidism, a rare disorder” U.S. Food and Drug Administration (FDA) (Press release). 9 August 2024.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Food and Drug Administration (FDA).

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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).

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

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New Drug Approvals

SEPTEMBER 20, 2023

1] Motixafortide was approved for medical use in the United States in September 2023. [2] 4 Similar in mechanism to the previously approved plerixafor , motixafortide is an inhibitor of C-X-C Motif Chemokine Receptor 4 (CXCR4), a protein that helps to anchor stem cells to bone marrow matrix. 1] It is given by subcutaneous injection. [1]

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The Pharma Data

AUGUST 16, 2021

Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. This authorization is based on information from an independent report evaluating safety and effectiveness of a third dose in people who received solid organ transplants. In the U.S.,

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New Drug Approvals

DECEMBER 24, 2023

S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Retrieved 21 December 2023. ^ “Wainua (eplontersen) granted regulatory approval in the U.S. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. Retrieved 22 December 2023. hdl : 10665/340684.

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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] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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New Drug Approvals

APRIL 30, 2025

N-Acetyl-D, L-leucine Unlike the majority of chemical syntheses of active principles where it is desirable to separate the enanti omers and / or to retain the selective stereo information during the synthesis steps, the synthesis of N-acetyl-D, L-leucine is carried out from L-leucine and therefore involves a racemization step. March 2023).

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The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. For more information, please visit www.radiuspharm.com. For more information, please visit www.benuvia.com.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. About the Phase 2/3 Study.

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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 RYBREVANT™ IMPORTANT SAFETY INFORMATION 7.

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The Pharma Data

NOVEMBER 2, 2020

Currently, Amazon only offers special license for point of care and professional use medical products, which would preclude the individual use GenViro kit from being available on Amazon, even after FDA approval is secured. CONTACT INFORMATION: Decision Diagnostics Corp. Two of the company’s.

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Agency IQ

APRIL 26, 2024

For instance, it would be acceptable for a biosimilar’s labeling to differ from its reference product for the purpose of providing information necessary to inform its safe and effective use (e.g., In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. Yes, the guidance confirms.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. IMPORTANT SAFETY INFORMATION.

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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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The Pharma Data

AUGUST 19, 2021

The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. For further information, please see [link]. About Lenacapavir.

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The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL) in addition to Original Concentration Humira.”

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The Pharma Data

DECEMBER 31, 2020

–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced that the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies remains under review by the U.S. 1, 2021 11:59 UTC.

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The Pharma Data

OCTOBER 30, 2020

Regeneron is also informing the U.S. 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

MARCH 27, 2022

. “We’re excited OLUMIANT may be a potential first-in-disease medicine approved this year for adults with severe alopecia areata.” OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S. See the full Prescribing Information here.

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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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Advarra

JULY 19, 2022

For more information on key components of a fit-for-purpose, phase-by-phase QMS guidance download Advarra’s whitepaper Steps to Implementing a Quality Management System. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records. Q: What must be done to prove oversight?

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The Pharma Data

DECEMBER 17, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION. Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

JANUARY 12, 2021

Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Source link.

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