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 290

FDA Approval Drugs Protein Development 290

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 325

FDA Approval Drugs Marketing 325

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 Drugs Clinical Trials Clinical Trials 246

Bio Pharma Dive

MAY 23, 2023

But the drug’s sales potential isn’t clear, and a top competitor is close behind. The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future.

FDA Approval 204

FDA Approval Drugs Sales 204

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 Drugs Trials Regulation 246

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

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 Gene Clinical Development Pharmacy 246

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

Drugs 321

Drugs FDA Approval Trials 321

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

FDA Approval 130

FDA Approval Manufacturing Protein Drugs 130

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.

FDA Approval 264

FDA Approval Trials Clinical Development Drugs 264

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

FDA Approval 130

FDA Approval Bacteria Drugs Pharma Companies 130

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 Drugs Trials 246

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 345

FDA Approval Drugs Clinical Trials Clinical Trials 345

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Indivior’s Opvee (nalmefene) nasal spray to reverse opioid overdose. Opvee is indicated for the emergency treatment of known or suspected opioid overdose in adults and paediatric patients aged 12 years and above.

FDA Approval 130

FDA Approval Drugs Trials Development 130

Fierce Pharma

MAY 19, 2023

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21

FDA Approval 127

FDA Approval Drugs 127

Bio Pharma Dive

MAY 24, 2023

The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

FDA Approval 290

FDA Approval Drugs Development 290

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Trofinetide is a synthetic version of the tripeptide glycine-proline-glutamate (GPE) naturally occurring molecule.

FDA Approval 182

FDA Approval Drugs Trials 182

Bio Pharma Dive

MARCH 7, 2023

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

FDA Approval 360

FDA Approval Drugs Protein Development 360

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

FDA Approval 264

FDA Approval Genetics Life Science Trials 264

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 325

FDA Approval Drugs Medicine Sales 325

Bio Pharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

FDA Approval 345

FDA Approval Medicine Protein Drugs 345

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Antibody 130

Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease.

FDA Approval 147

FDA Approval Trials Drugs Regulation 147

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 Antibody 264

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 336

FDA Approval Drugs 336

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharmaceutical Technology

APRIL 27, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) in children aged between two and five years with certain mutations.

FDA Approval 246

FDA Approval Drugs In-Vitro Gene 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 328

FDA Approval Drugs 328

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 132

FDA Approval Drugs 132

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 162

FDA Approval Drugs 162

Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). Furthermore, the company intends to commercialise the drug in the country within a few weeks.

FDA Approval 147

FDA Approval Drugs Trials Development 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 354

FDA Approval Drugs Branding 354

Pharmaceutical Technology

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval Clinical Trials Clinical Trials Antibody 246

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The post Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis appeared first on Pharmaceutical Technology.

FDA Approval 147

FDA Approval Clinical Trials Clinical Trials Drugs 147

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019.

Drugs 264

Drugs FDA Approval Containment Scientist 264

Pharmaceutical Technology

SEPTEMBER 30, 2022

These approvals represent crucial milestones for bluebird bio, the gene therapy field, and patients with rare genetic diseases. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.

Gene Therapy 289

Gene Therapy FDA Approval Gene Genetic Disease 289