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. 20 August 2024. 20 August 2024.

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The Pharma Data

MAY 4, 2021

Posted 04 May 2021 | By Michael Mezher . Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. © 2021 Regulatory Affairs Professionals Society.

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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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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). . TOKYO and CAMBRIDGE, England , Dec.

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New Drug Approvals

JUNE 29, 2025

Jump up to: a b c d e f g h “FDA approves taletrectinib for ROS1-positive non-small cell lung cancer” U.S. Food and Drug Administration (FDA). World Health Organization (2021). 26 (6): 765–772. doi : 10.1080/14656566.2025.2487150. PMID 40170301. 11 June 2025. Retrieved 13 June 2025. Jump up to: a b “U.S.

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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]

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. 28, 2021).

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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. 1.1.529), in December 2021 WHO reported that interleukin-6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.9. A decision on 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. World Health Organization (2021). 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. 22 December 2023.

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The Pharma Data

JANUARY 5, 2021

06, 2021 (GLOBE NEWSWIRE) — Radius Health, Inc. The Company plans to initiate a pivotal Phase 2/3 study for patients with Prader-Willi syndrome (“PWS”) in the second half of 2021 pending regulatory discussion with the U.S. Food and Drug Administration (“FDA”). BOSTON, Jan. Davis, executive chairman of Benuvia.

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New Drug Approvals

SEPTEMBER 8, 2024

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). World Health Organization (2021). Text was copied from this source which is copyright European Medicines Agency. 9 August 2024. 15 September 2023.

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

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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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing or planned. In the U.S.,

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The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

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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). January 2021). August 2021). 1] It is the L -form of acetylleucine. .

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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. In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S.

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The Pharma Data

JUNE 28, 2021

The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

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The Pharma Data

OCTOBER 27, 2021

Data from the trial was presented before this time as an oral donation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting. Primary analysis data blazoned at ASCO 2021 showed Kymriah led to responses for the maturity of cases treated, with 66 achieving a complete response (95 CI, 56-75).

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In the U.S.,

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. FDA-2022-E-3124 ). 6,992,207 covering PEPAXTO (Docket No.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. WAKEFIELD, Mass.,

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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

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

DECEMBER 31, 2020

1, 2021 11:59 UTC. –( 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.

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The Pharma Data

JANUARY 6, 2021

6, 2021– Moderna, Inc. The European Union is the fourth jurisdiction to authorize Moderna’s COVID-19 vaccine, following the United States on December 18, 2020, Canada on December 23, 2020 and Israel on January 4, 2021. Posted: January 2021. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. CAMBRIDGE, Mass.–(BUSINESS

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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 28 October 2021. FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release).

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The Pharma Data

DECEMBER 8, 2020

BioAge is on the cusp of taking pilot therapies BGE-117 and BGE-175 into clinical trials, targeting the first half of 2021. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Series D funds will be used to accelerate reimbursement coverage for its three commercial products. .

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The Pharma Data

JANUARY 12, 2021

12, 2021– Moderna, Inc. The authorization is given according to the ordinary approvals procedure and is based on a rolling submission of data and the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30. Posted: January 2021.

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The Pharma Data

MARCH 27, 2022

These 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published today in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatology and Venereology (EADV) Congress. It is approved in the U.S. ” About OLUMIANT®.

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The Pharma Data

DECEMBER 29, 2020

. “We look forward to the continued findings from our other ongoing Phase III studies of PRX-102, with the final results from the BRIGHT study expected in the first quarter of 2021, and interim results from the BALANCE study expected in the first half of 2021.” Protalix has licensed to Pfizer Inc.

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The Pharma Data

FEBRUARY 4, 2021

Percent on a GAAP Basis – Provides 2021 GAAP Diluted EPS Guidance Range of $6.69 to $6.89; Provides 2021 Adjusted Diluted EPS Guidance Range of $12.32 3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. Full-Year 2021 Outlook.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

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The Pharma Data

DECEMBER 17, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

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The Pharma Data

OCTOBER 30, 2020

Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.

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The Pharma Data

DECEMBER 15, 2020

Also in September, the FDA accepted a new drug application ( NDA ) from ChemoCentryx seeking approval for its investigational candidate, avacopan, for treating anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis), a rare autoimmune disease. The FDA has set an action date of July 7, 2021.

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The Pharma Data

NOVEMBER 20, 2020

In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. Posted: November 2020.

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