The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. Investor Relations Contact: Peter Schwartzman Email: investor-relations@radiuspharm.com Phone: 617-583-2017.

Disease

The Pharma Data

DECEMBER 8, 2020

CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Headquartered in Shanghai, the company will also have a hub in Philadelphia.

RNA

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 8,128,929 [] for [PTE] request under 35 U.S.C. §

FDA

The Pharma Data

DECEMBER 15, 2020

In September, Corbus Pharmaceuticals Holdings announced topline results from its 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc), a rare life-threatening multi-system autoimmune disease for which there are no FDA-approved treatments.

Disease

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.” suppositories).

FDA

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017.

FDA

Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. FDA in October 2023. The product was approved in the E.U. However, BeiGene announced that it is seeking approval in the U.S.

Biosimilars

Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use.

FDA

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

Clinical Trials

The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. .

Production

The Pharma Data

AUGUST 20, 2020

. Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. cases per 100,000 population in 2017.

FDA Approval

The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Key innovation milestones: Entresto granted an expanded indication by the FDA in chronic heart failure patients (to include HFpEF). New approvals. billion, zero coupon bond issued in March 2017 at maturity.

Production

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. See 2023 Mich.

Testimonials

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

FDA

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA Approval

New Drug Approvals

MAY 30, 2025

PATENT [link] PATENT CN112457267 [link] REF Satish Kumar RangarajuSatish Kumar Rangaraju The first FDA-approved treatment for Demodex Blepharitis, a common eyelid disease caused by microscopic mites living in the eyelashes’ hair follicles. Food and Drug Administration (FDA). Food and Drug Administration (FDA).

FDA Approval

New Drug Approvals

APRIL 15, 2025

2] Society and culture Legal status Ensartinib was approved for medical use in the United States in December 2024. [2] Jump up to: a b c d e f g “FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer” U.S. Food and Drug Administration (FDA). Xcovery Holdings, Inc.

FDA

New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Food and Drug Administration (FDA). Flurpiridaz F 18 WeightAverage: 367.84 27 September 2024.

FDA

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.

Therapies

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S. Food and Drug Administration (FDA). 61 (17): 78627876.

FDA Approval