STAT News

DECEMBER 12, 2022

The new medicine, a pill called Krazati, was cleared to treat patients with advanced non-small cell lung cancer containing a specific type of KRAS alteration called G12C. The mutation is found in approximately 13% of lung tumors. Continue to STAT+ to read the full story…

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XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. In the EU, Skyclarys has been granted the Orphan Drug designation and is under review by the European Medicines Agency (EMA). What is Friedreich’s Ataxia?

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Pharmacy Checkers

NOVEMBER 12, 2020

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Kesselheim called “ Reputation and Authority FDA and the Fight over U.S.

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XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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Drug Discovery World

FEBRUARY 6, 2023

It contains new long-term survival data of children enrolled in a Phase III trial showing durability of treatment effect through at least four years. “There is an urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD” said Dr Silviu Itescu, Chief Executive of Mesoblast.

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XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

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The Pharma Data

NOVEMBER 29, 2021

“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” said Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By The FDA, an agency within the U.S.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. Today, the U.S.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Gauden, CEO of Blue Earth Diagnostics, in the company’s news release.

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XTalks

AUGUST 9, 2023

This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years,” said Christopher Starr, MD, associate professor of ophthalmology at Weill Cornell Medicine, New York Presbyterian Hospital, in the company’s press release. What Is Demodex Blepharitis?

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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] Janssen Biotech, Inc.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx (relugolix) FDA Approval History.

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XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

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The Pharma Data

JULY 8, 2021

One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. For more information about Eisai Co., please visit [link]. Biogen Safe Harbor.

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The Pharma Data

FEBRUARY 1, 2021

Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of Plegridy; and the results of certain real-world data. Source: Biogen.

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The Pharma Data

NOVEMBER 2, 2020

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols and triglycerides, according to company data.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Our ambition is to be the world’s leading and most valued generics company.

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Pfizer

SEPTEMBER 27, 2022

Biosimilars are FDA approved, and often offer a lower-cost alternative to biologic therapies that treat challenging diseases like cancer, diabetes, and rheumatoid arthritis. Price controls would base the price of medicines sold in the U.S. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted

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XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

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Pfizer

AUGUST 3, 2022

The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac, renal and inherited metabolic disorders. Disclosure Notice. 07.13.2022.

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

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The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. Recently, US Food and Drug Administration (FDA) also approved the citrate-free HCF of Hyrimoz ® (adalimumab-adaz) injection.

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Drug Discovery World

SEPTEMBER 14, 2023

8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study. References Wong MCS, et al.

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pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. The past few weeks have seen a flurry of companies in this space announce that they intend to go public. .

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pharmaphorum

NOVEMBER 9, 2021

Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system. Also, Bristol-Myers Squibb was recently successful in gaining FDA approval for Opdivo to be used as an earlier line treatment for post-surgical treatment of invasive bladder cancer.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

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Camargo

NOVEMBER 11, 2020

Approval of the Month: Companion Diagnostic for Bayer’s Vitrakvi Should Lead to Improved Patient Outcomes. In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics.

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