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

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

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

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

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

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

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

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

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

Bio Pharma Dive

MARCH 26, 2024

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

FDA Approval 280

FDA Approval Drugs 280

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 193

FDA Approval Drugs Medicine Clinical Trials 193

pharmaphorum

MARCH 26, 2024

MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms

FDA Approval 97

FDA Approval Drugs 97

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

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

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

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

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

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

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

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

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

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

Pharmaceutical Technology

APRIL 29, 2024

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

Gene Therapy 245

Gene Therapy Gene FDA Approval Drugs 245

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 108

FDA Approval Drugs 108

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

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

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

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 120

FDA Approval Marketing Drugs 120

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

Bio Pharma Dive

DECEMBER 1, 2022

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

FDA Approval 358

FDA Approval Medicine Drugs Research 358

Bio Pharma Dive

MAY 28, 2021

Lumakras is the first drug proven effective. For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers.

FDA Approval 361

FDA Approval Drugs Gene Scientist 361

Bio Pharma Dive

JANUARY 25, 2021

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

FDA Approval 327

FDA Approval Drugs Development 327

Bio Pharma Dive

MAY 13, 2022

Called Radicava ORS, this version is taken by mouth rather than via an hourlong infusion, which may help improve the drug's convenience and use.

FDA Approval 265

FDA Approval Drugs 265

Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. It is not indicated to treat CDI.

FDA Approval 246

FDA Approval Regulation Trials Development 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