Drugs.com

APRIL 1, 2025

Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency announced Friday.Women with. TUESDAY, April 1, 2025 -- The U.S.

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BioPharma Drive: Drug Pricing

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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Drugs.com

JUNE 13, 2023

Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a. TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition.

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Drugs.com

JUNE 13, 2023

Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a. TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition.

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SCIENMAG: Medicine & Health

JULY 26, 2023

July 26, 2023 – Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. PARAMUS, N.J.,

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Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Many drugs fail because they simply aren’t safe. Seal began this work after wondering if more toxicology insights could be gleaned from a drug candidate’s chemical structure.

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Drug Patent Watch

AUGUST 12, 2020

Just because a drug has received FDA approval does not mean that it is available in the marketplace. The post Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) gave a greenlight for ViiV Healthcare ’s Cabenuva. Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant.

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ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development. CBRN MCMs).

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New Drug Approvals

MAY 8, 2025

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 14] Pirtobrutinib was approved for medical use in the European Union in November 2023. [2] 14] Pirtobrutinib was approved for medical use in the European Union in November 2023. [2]

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SCIENMAG: Medicine & Health

NOVEMBER 16, 2023

Over the last four decades, insulin manufacturers have extended their periods of market exclusivity on brand-name insulin products by employing several strategies, including filing additional patents on their products after FDA approval and obtaining many patents on delivery devices for their insulin products.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA.

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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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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

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The Pharma Data

NOVEMBER 2, 2020

Food and Drug Administration, Gover said he believes there is a “clear path” to the submission of a New Drug Application as soon as 2021. If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. Now is the ideal time to develop nabiximols in the U.S.

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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

OCTOBER 30, 2020

To increase demand for products during the novel coronavirus pandemic, the US Food and Drug Administration (FDA) has already approved at-home testing and investigated the effectiveness of malaria pills and other antiviral drugs to treat Covid-19 9. FDA approves first treatment for Covid-19.

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. Unlike other catheters on the market, the TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall.

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Advarra

JULY 26, 2022

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. With the exception of one highly purified form of CBD (Epidiolex), no other CBD products are currently FDA approved.

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The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. ” According to Global Data, the global market for influenza antivirals reached 2.34 TAIPEI, Taiwan , Nov. billion USD by 2026 at a CAGR of 11.5%.

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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] Crinecerfont was approved for medical use in the United States in December 2024. [2] Food and Drug Administration (FDA).

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The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. NGENLA is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States.

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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. BRIDGEWATER, N.J., and Canada.

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The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S.

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The Pharma Data

AUGUST 20, 2020

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is launching the drug in a dimethyl fumarate delayed-release oral solid formulation, both in 120mg and 240mg doses. The drug generated $3.79 billion for Biogen through 2019. Matt Fellows.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S.

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The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

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Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. First, drug prices in the U.S. He points to “a mere 1.5%

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FDA Law Blog: Biosimilars

JUNE 27, 2023

Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. HP&M’s James E. Valentine , as a 2023 Rising Star.

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The ChEMBL-og

FEBRUARY 22, 2021

Updated drug safety information is available (as of ChEMBL 28 ) for drugs with boxed warnings and for withdrawn drugs. Boxed warnings (also know as black box warnings) are provided on medicinal product labels for FDA approved drugs if the medicinal product can cause severe or life-threatening side effects.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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The Pharma Data

DECEMBER 3, 2020

Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older. Under the EAMS, patients with HAE in the UK aged 12 and older can gain access to the drug for the routine prevention of recurrent attacks.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. Leveraging the experience gained from the development and marketing of a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform.” Biogen (Nasdaq: BIIB) and Eisai Co.,

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The Connected Lab

APRIL 8, 2020

Prescription drugs have the ability to transform a patient’s life and provides them the opportunity to rid a devastating illness, making the development and approval of these medications urgent and necessary. However, over the last 10 years the path leading to drug approval has become more complicated and expensive.

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The Pharma Data

JANUARY 25, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for VLX-1005 for the treatment of heparin induced thrombocytopenia (HIT). “We We are pleased the FDA has granted Orphan Drug Designation for VLX-1005 for prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia,” said Jeffrey W.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet].

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