Bio Pharma Dive

MARCH 15, 2024

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

FDA Approval 300

FDA Approval Doctors Doctor Drugs 300

Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

FDA Approval 264

FDA Approval Trials Genetics Drugs 264

Bio Pharma Dive

FEBRUARY 23, 2023

Sanofi and its development partner, Sobi, claim the drug’s once-a-week dosing, and its effect on blood-clotting protein levels, will help it compete in the crowded market for hemophilia A treatments.

FDA Approval 273

FDA Approval Drugs Protein Marketing 273

Pharmaceutical Technology

JULY 8, 2022

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients.

FDA Approval 246

FDA Approval HR Drugs Hormones 246

Pharmaceutical Technology

NOVEMBER 13, 2023

On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).

FDA Approval 130

FDA Approval Drugs 130

BioSpace

APRIL 8, 2024

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu is the first FDA-approved tumor-agnostic HER2-targeted therapy authorized for the treatment of solid tumors in adults who have undergone prior systemic treatment.

FDA Approval 111

FDA Approval Antibody Drugs 111

Bio Pharma Dive

APRIL 26, 2023

The drug is the first microbiota-based pill to win U.S. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff infections.

FDA Approval 294

FDA Approval Drugs 294

BioSpace

APRIL 3, 2024

Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.

FDA Approval 109

FDA Approval Drugs 109

Bio Pharma Dive

MARCH 28, 2024

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

FDA Approval 273

FDA Approval Drugs 273

Bio Pharma Dive

APRIL 4, 2023

The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.

FDA Approval 311

FDA Approval Drugs Marketing 311

Bio Pharma Dive

SEPTEMBER 11, 2023

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

FDA Approval 306

FDA Approval Drugs Antibody 306

Fierce Pharma

APRIL 3, 2024

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

FDA Approval 105

FDA Approval Drugs 105

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 12, 2023

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.​

FDA Approval 192

FDA Approval Drugs Medicine Clinical Trials 192

Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

FDA Approval 341

FDA Approval Clinical Trials Clinical Trials Drugs 341

Bio Pharma Dive

JANUARY 30, 2023

The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK.

FDA Approval 327

FDA Approval Drugs 327

Pharmaceutical Technology

SEPTEMBER 21, 2023

On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.

FDA Approval 130

FDA Approval Drugs 130

Pharmaceutical Technology

MARCH 1, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. The post US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica appeared first on Pharmaceutical Technology.

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

APRIL 23, 2024

The US Food and Drug Administration (FDA) has granted approval for ImmunityBio's ANKTIVA, plus Bacillus Calmette-Guérin (BCG), for treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

FDA Approval 130

FDA Approval Drugs 130

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

FDA Approval 147

FDA Approval Drugs 147

Bio Pharma Dive

MAY 13, 2022

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

FDA Approval 352

FDA Approval Drugs Branding 352

Fierce Pharma

NOVEMBER 16, 2023

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

FDA Approval 127

FDA Approval Marketing Drugs 127

Bio Pharma Dive

JANUARY 11, 2023

Airsupra joins a growing portfolio of new drugs that are helping the British drugmaker offset wilting sales of older respiratory medicines like Pulmicort.

FDA Approval 311

FDA Approval Drugs Sales Medicine 311

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1).

FDA Approval 246

FDA Approval Trials Medicine Drugs 246

Bio Pharma Dive

NOVEMBER 18, 2022

To be sold as Tzield, the drug will cost $193,900 for a typical full regimen. Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes.

FDA Approval 315

FDA Approval Drugs 315

Bio Pharma Dive

NOVEMBER 16, 2023

Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.

FDA Approval 262

FDA Approval Drugs Production 262

Pharmaceutical Commerce

JANUARY 15, 2024

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

FDA Approval 107

FDA Approval Drugs 107

Pharmaceutical Technology

MARCH 10, 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine.

FDA Approval 246

FDA Approval Pharmacy Trials Clinical Development 246

Bio Pharma Dive

MARCH 23, 2023

Rezzayo is the first new treatment for candidemia and invasive candidiasis to win FDA approval in years.

FDA Approval 148

FDA Approval Drugs 148

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients.

FDA Approval 246

FDA Approval Medicine Trials Drugs 246

Bio Pharma Dive

DECEMBER 6, 2023

The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.

FDA Approval 288

FDA Approval Drugs Development 288

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

pharmaphorum

SEPTEMBER 18, 2023

GSK gets wide FDA approval for myelofibrosis drug Phil.Taylor Mon, 18/09/2023 - 07:31 Bookmark this

FDA Approval 100

FDA Approval Drugs 100

Bio Pharma Dive

AUGUST 25, 2023

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

FDA Approval 246

FDA Approval Regulation Drugs Medicine 246

Fierce Pharma

MAY 1, 2023

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35

FDA Approval 121

FDA Approval Drugs 121

pharmaphorum

OCTOBER 18, 2023

UCB bags FDA approval for second myasthenia gravis drug Phil.Taylor Wed, 18/10/2023 - 10:49 Bookmark this

FDA Approval 96

FDA Approval Drugs 96

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD).

FDA Approval 246

FDA Approval Trials Drugs 246