Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

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 approves oral version of Mitsubishi's ALS drug

Bio Pharma Dive

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

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5 FDA approval decisions to watch in the first quarter

Bio Pharma Dive

The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug as well as mark the start of a price battle in oncology

5 FDA approval decisions to watch in the fourth quarter

Bio Pharma Dive

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too

Veklury Becomes the First FDA-Approved COVID-19 Treatment for Children Under 12

XTalks

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. This is the only approved COVID-19 treatment for children under 12 years of age.

In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

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

In a first, FDA approves an 'interchangeable' biosimilar for diabetes

Bio Pharma Dive

An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs

5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June

FDA approves first CAR-T cell therapy for multiple myeloma

Bio Pharma Dive

Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma

Seagen, Genmab win speedy FDA approval for cervical cancer drug

Bio Pharma Dive

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019

Takeda wins FDA approval for targeted lung cancer drug

Bio Pharma Dive

Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally

Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors

5 FDA approval decisions to watch in the 1st quarter

Bio Pharma Dive

By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment

FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

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 approves Lilly, Boehringer diabetes drug for heart failure

Bio Pharma Dive

The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance

5 FDA approval decisions to watch in the 4th quarter

Bio Pharma Dive

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

Pharma Phorum

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. .

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Bio Pharma Dive

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness

FDA approves new epilepsy drug, handing Marinus a long-awaited victory

Bio Pharma Dive

Nearly 20 years since its founding, Marinus Pharmaceuticals will make the leap to a commercial-stage biotechnology company with Friday's approval of Ztalmy

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

regulator granted a full approval after allowing emergency use earlier this year. The U.S. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness

Roche wins FDA approval for rival to Regeneron's lucrative eye drug

Bio Pharma Dive

The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants

GSK immunotherapy wins FDA approval, joining crowded cancer drug class

Bio Pharma Dive

Jemperli is the seventh drug cleared by the FDA that blocks either PD-1 or PD-L1 proteins, joining Merck's Keytruda, Bristol Myers' Opdivo and others

MacroGenics wins FDA approval of breast cancer drug

Bio Pharma Dive

Margenza, which bested Roche's Herceptin in a head-to-head study, offers a new option to patients with HER2-positive metastatic breast cancer who have already tried other regimens

FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi

Bio Pharma Dive

AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent

Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

Bio Pharma Dive

The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however

Biohaven to seek FDA approval for second migraine drug after study success

Bio Pharma Dive

The biotech's drug, called zavegepant, is delivered intranasally and could offer a similar convenience advantage as its first, the fast-selling Nurtec ODT

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Bio Pharma Dive

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects

FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer

Bio Pharma Dive

Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely

FDA approves first biosimilar to top-selling eye drug Lucentis

Bio Pharma Dive

The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency

In historic move, FDA approves a closely watched and controversial Alzheimer's drug

Bio Pharma Dive

With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives

US FDA approves first interchangeable biosimilar

BioPharma Reporter

Yesterday saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar drug. Markets & Regulations

FDA approves Regeneron antibody drug as first Ebola virus treatment

Bio Pharma Dive

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19

Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

Bio Pharma Dive

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.

Merck, Bayer win FDA approval for heart failure drug

Bio Pharma Dive

The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study

AstraZeneca metastatic breast cancer treatment secures FDA approval

BioPharma Reporter

The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.

Heron, on third attempt, secures FDA approval for non-opioid painkiller

Bio Pharma Dive

The San Diego-based biotech's drug, which will now be sold as Zynrelef, had perviously been rejected by the agency in 2019 and 2020

Eagle Pharmaceuticals Receives FDA Approval for Vasopressin

BioTech 365

Eagle Pharmaceuticals Receives FDA Approval for Vasopressin Eagle Pharmaceuticals Receives FDA Approval for Vasopressin — Company is first to file an ANDA referencing Vasostrict®, which had total U.S.

Novo keeps price in line with FDA approval of second obesity shot

Bio Pharma Dive

Wegovy, a weekly drug, joins daily Saxenda in the pharma's portfolio, which could soon be under pressure from an experimental Lilly medicine

The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.

Bio Pharma Dive

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it

FDA approval for Xywav for idiopathic hypersomnia in adults

Pharma Times

First and only FDA-approved treatment for the neurological sleep disorder