The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

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The Pharma Data

JANUARY 17, 2021

FDA approval this year. LAPS GLP-2 Analog was also designated as an orphan drug by FDA and EMA in 2019 and was subsequently designated as a drug for rare pediatric diseases (RPDs) by FDA in 2020. . Hanmi Pharmaceutical Co., Hanmi Pharmaceutical Co., .

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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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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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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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Drug Discovery World

FEBRUARY 15, 2024

As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose. There are very few treatments available to treat opioid use disorder (OUD) and we do believe the ones that are FDA approved should be made widely available to patients. The post Can an antibody therapy prevent fentanyl overdoses?

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Drug Discovery World

OCTOBER 18, 2023

Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. Food & Drug Administration (2019) FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. 2019; 381(24):2293-2303. TARRYTOWN, N.Y., Posted: October 2020.

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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

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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The Pharma Data

MARCH 31, 2023

In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products.

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Drug Discovery World

SEPTEMBER 14, 2023

N Engl J Med 2019; 381(4):338-348. “Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. Fernandez E, et al. J Clin Med. 2022;11(15): 4483.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS –(BUSINESS WIRE)– Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Source link.

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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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The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide.

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Drug Discovery World

MARCH 7, 2023

She has previously been named an MIT Technology Review Top Innovator Under 35, a Forbes 50 Top Women In Tech, a Deloitte Fast 50 Women in Leadership, and has won several prizes, including CEO of Year 2019 at the Cambridge Independent Science and Technology Awards and Best Female-Led Startup at the StartUp Europe Awards in 2019.

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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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The Pharma Data

MAY 6, 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 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 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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Drug Discovery World

DECEMBER 13, 2023

Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2. Indeed, therapeutics based on single-domain antibodies are already making their way through the clinical development pipeline for the treatment of cancer, autoimmune diseases, infectious diseases and rare diseases.

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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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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

This occurred in January 2022 when the Departments issued additional guidance , which discussed reports of denial of coverage in violation of the ACA requirement and provided a reminder to plans and issuers of their responsibilities under the statute and 2019 HRSA Guideline (FAQ Part 51, Q9).

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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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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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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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Drug Discovery World

JULY 13, 2023

The FDA says that it permits some unapproved drugs to be marketed if they are relied on by healthcare professionals to treat serious medical conditions when there is no FDA-approved drug to treat the condition or there is insufficient supply of FDA-approved drugs.

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The Pharma Data

JUNE 6, 2022

1] [2] In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries. [3].

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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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Drug Target Review

FEBRUARY 15, 2024

12 That drug (tecovirimat) is now FDA-approved and stockpiled by the US and other governments for smallpox treatment, 13 while also being used in clinical practice globally for treatment of mpox and other viruses within the orthopox family. The development and approval of tecoviromat (TPOXX®), the first antiviral against smallpox.

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Drug Discovery World

APRIL 23, 2024

More than 413,000 service members were diagnosed with a TBI between 2000 and Q3 of 2019. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI. A number of studies of US service men and women give a good picture of links between concussion and subsequent diagnoses.

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The Pharma Data

APRIL 4, 2023

Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019.To ERLEADA ® received U.S. To date, more than 100,000 patients worldwide have been treated with ERLEADA ®.

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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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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Updated October 1, 2019.

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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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Drug Discovery World

AUGUST 14, 2023

A Mutual Recognition Agreement (MRA) 2 for inspections of manufacturing sites for certain human medicines, signed and implemented by the United States and EU in July 2019, served as an important milestone in harmonising certain regulatory aspects in developing a global drug.

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