New Drug Approvals

DECEMBER 24, 2023

3] In November 2023, capivasertib was approved in the United States for people with hormone receptor-positive, human epidermal growth factor receptor 2 -negative breast cancer when used in combination with fulvestrant. [3] Jump up to: a b c d e f “FDA approves capivasertib with fulvestrant for breast cancer” U.S.

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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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). Food and Drug Administration (FDA). 5 December 2023. . 5 December 2023.

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Advarra

JULY 19, 2022

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? Then you can submit an application for approval.

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Agency IQ

APRIL 26, 2024

Can information about a biosimilar product be included in promotional materials, even if it isn’t specifically included in the product’s actual FDA-approved labeling? Information regarding interchangeability would remain available only in the Purple Book: Database of Licensed Biological Products. Yes, the guidance confirms.

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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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Codon

MARCH 28, 2023

Although this article has a lot, too!) The rest of this article gives a brief history of DARPA and its neurotechnology programs. Researchers used an off-the-shelf, FDA-approved machine, developed by Blackrock Neurotech ; the algorithms were the main advancement.) Please reach out to suggest edits or additions.

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Related Articles: Zokinvy (lonafarnib) FDA Approval History.

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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Agency IQ

JANUARY 19, 2024

approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S. FDA in October 2023. The product was approved in the E.U. However, BeiGene announced that it is seeking approval in the U.S. Based on the E.U.

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Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

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Agency IQ

MAY 31, 2024

For example, states a footnote, sponsors can already “leverage their own data previously submitted in an [investigational new drug] IND, [new drug application] NDA, or [biologic license application] BLA” while other applicants can “leverage certain information in an approved NDA or BLA (e.g., which would never be acceptable.

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Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Thanks for skimming. ❤️ Subscribe to support human writers. Will Bedingfield.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada.

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Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

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Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

DECEMBER 1, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The following PDUFA dates were obtained from publicly available sources.

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The Anticancer Fund

JUNE 23, 2023

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells.

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Codon

MAY 18, 2023

The company behind the tomato, Sanatech Seeds , claims that eating GABA can help relieve stress and lower blood pressure," the WIRED article says. And the article doesn’t mention how Pairwise engineered the mustard to be “less pungent.” The whole article is confusing. Law enforcement officials don’t.

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Codon

MAY 18, 2023

The company behind the tomato, Sanatech Seeds , claims that eating GABA can help relieve stress and lower blood pressure," the WIRED article says. And the article doesn’t mention how Pairwise engineered the mustard to be “less pungent.” The whole article is confusing. Law enforcement officials don’t.

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New Drug Approvals

APRIL 8, 2025

Vimseltinib 1628606-05-2 DCC-3014 2/14/2025 FDA APPROVED, Romvimza 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one C 23 H 25 N 7 O 2 , 431.5 Food and Drug Administration (FDA) granted the application for vimseltinib priority review designation. [2] 2022.128928.

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New Drug Approvals

APRIL 2, 2025

1] Society and culture Legal status Benzgalantamine was approved for medical use in the United States in July 2024. [1] Jump up to: a b c [link] ^ “Alpha Cognition’s Oral Therapy Zunveyl Receives FDA Approval to Treat Alzheimer’s Disease” (Press release). 8 August 2024. Retrieved 15 August 2024.

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New Drug Approvals

APRIL 9, 2025

1] Gepotidacin was approved for medical use in the United States in March 2025. [1] “FDA approval” Reuters. ^ “GSK’s investigational antibiotic granted FDA priority review for urinary tract infections” PMLiVE. 1] [2] It is used as the salt gepotidacin mesylate, and is taken by mouth. [1]

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New Drug Approvals

APRIL 5, 2025

Jump up to: a b “FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS” U.S. Food and Drug Administration (FDA). This article incorporates text from this source, which is in the public domain. ^ “Novel Drug Approvals for 2025” U.S.

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Drug Target Review

MARCH 20, 2025

“This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted. These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication.

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Codon

FEBRUARY 23, 2025

This article concludes Issue 05. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. million by 2004.

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Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. C-8 Personal Injury Litigation , 87 F.4th 4th 315 (6th Cir.

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Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN. In GenBioPro, Inc.

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