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).

FDA

New Drug Approvals

JULY 8, 2025

Salt Formation: The pritelivir free base is then reacted with methanesulfonic acid to form the mesylate salt, which is the active pharmaceutical ingredient (API). 7] If the virus also acquires resistance to foscarnet, then there is currently no FDA approved treatment.

Virus

BioPharma Drive: Drug Pricing

JULY 10, 2025

Outside of the FDA, Kennedy last month abruptly fired all 17 members of an advisory panel to the CDC, replacing them with his own hand-selected advisers, who don’t all have the typical background and experience in epidemiology and vaccine science. This panel, known as ACIP for short, recommends who should receive FDA-approved vaccines.

Vaccine

BioPharma Drive: Drug Pricing

JULY 30, 2025

Published July 30, 2025 Ned Pagliarulo Lead Editor post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well as updates from Apellis Pharmaceuticals, PTC Therapeutics and Arrowhead Pharmaceuticals that you may have missed.

Drugs

New Drug Approvals

AUGUST 2, 2025

Accordingly, an object of the present invention is to provide a novel production method capable of stably supplying sepiapterin, lactoylpterin and tetrahydrolactoylpterin, which have recently been found to be useful as pharmaceuticals. 2] [3] Sepiapterin was approved for medical use in the United States in July 2025. [1]

Production

Drug Patent Watch

APRIL 8, 2025

Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. From improved access to affordable medications to increased competition in the market, generics have revolutionized the way we approach healthcare.

FDA Approval

Drug Patent Watch

APRIL 29, 2025

"Market Access: The Hidden Hurdle in Generic Drug Commercialization As a seasoned pharmaceutical professional, I've seen it time and time again: a generic drug finally receives FDA approval, only to stall in the market due to a seemingly insurmountable obstacle - market access.

Marketing

BioPharma Drive: Drug Pricing

OCTOBER 13, 2023

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

FDA Approval

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.

FDA Approval

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc.

FDA Approval

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex. “The

FDA Approval

Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

Pharmaceuticals

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. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.

FDA Approval

Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Go-to-market Strategy. If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement.

Production

The Pharma Data

NOVEMBER 2, 2020

GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States. Sativex is approved for use in parts of Europe for this indication. Justin Gover, chief executive officer of GW Pharmaceuticals, proclaimed his excitement about launching the Phase III study in the United States.

FDA Approval

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.

FDA Approval

DrugBank

DECEMBER 18, 2024

A new shift is occurring in the pharmaceutical industry, leading to a rapidly expanding field known as digital therapeutics (DTx). DTx interventions include sensor-equipped wearable devices, remote patient monitoring tools, and virtual reality platforms integrated with conventional pharmaceutical treatments.

Pharmaceuticals

The Pharma Data

JULY 29, 2021

Biosimilars marketed in the U.S. The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products. The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc.

Biosimilars

FDA Law Blog: Biosimilars

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. In addition to Mr.

Science

The Pharma Data

DECEMBER 3, 2020

BioCryst Pharmaceuticals, Inc. 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. announced on Thursday that the U.S.

FDA Approval

The Pharma Data

DECEMBER 16, 2020

–( BUSINESS WIRE )– ANI Pharmaceuticals, Inc. , (“ANI” or the “Company”) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval and the launch of Aminocaproic Acid Tablets USP, 500mg. market for this product is approximately $12.7 ANI Pharmaceuticals, Inc. BAUDETTE, Minn.–(

Pharmaceuticals

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. drug market is connected to foreign markets with lower drug prices.

Pharmacy

The Pharma Data

JULY 8, 2021

is a leading global pharmaceutical company headquartered in Japan. Leveraging the experience gained from the development and marketing of a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform.”

Clinical Trials

The Pharma Data

MAY 7, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Licensing

The Pharma Data

JANUARY 19, 2021

19, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. financial markets open. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Friday, February 5, 2021 , before the U.S. Source link.

FDA Approval

The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

Clinical Trials

FDA Law Blog: Biosimilars

APRIL 21, 2024

Taiho Pharmaceutical Co., Usually at this point in a post we would identify the date of approval of the relevant NDA. But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ?

FDA

The Pharma Data

DECEMBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. , (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. RANCHO CUCAMONGA, Calif., ” According to IQVIA, the U.S.

FDA

The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

FDA Approval

The Pharma Data

JUNE 22, 2023

Paulsen, who joined Ferring’s Board of Directors 1 in July 2021, played a leading role in securing the US approval of Adstiladrin ® (nadofaragene firadnovec-vncg) a first-in-class gene therapy offering a new approach to treating a severe form of BCG-unresponsive non-muscle invasive bladder cancer. Ad hoc announcement pursuant to Art.

Pharmaceuticals

FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

Compliance

The ChEMBL-og

FEBRUARY 22, 2021

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. For medicinal products that contain one active pharmaceutical ingredient, a boxed warning can be directly linked to a drug.

Drugs

The Connected Lab

APRIL 8, 2020

The cost to develop a new prescription medicine that gains market approval has gone up 145% to $2.6 For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3.

Pharma Companies

The Pharma Data

JUNE 17, 2022

“By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.”. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

Biosimilars

The Pharma Data

DECEMBER 4, 2021

–(BUSINESS WIRE)– Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. You are encouraged to report side effects of prescription drugs to the FDA. Teva Pharmaceutical Industries Ltd.

Doctors

New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] Food and Drug Administration (FDA) (Press release). 14 August 2024.

FDA

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. Furthermore, nearly one third of drugs get withdrawn from the market post approval due to safety concerns. link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet].

Drugs