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

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

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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

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 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

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

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

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

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

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

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

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 approval for Xywav for idiopathic hypersomnia in adults

Pharma Times

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

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

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.

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

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

CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

Pharma Mirror

The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.

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

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

Pharma Phorum

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market.

FDA approves Regeneron drug for rare, genetic form of high cholesterol

Bio Pharma Dive

The biotech set an average annual price of $450,000 for the first-of-its-kind drug, which treats a condition that affects about 1,300 people in the U.S.

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

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

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial

BioTech 365

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial Neovasc Announces FDA Approval of COSIRA-II Clinical Trial Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. Neovasc” or the “Company”) … Continue reading → GlobeNewswire

FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis

BioTech 365

FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis FDA Approval Based on Positive Results of International, Multi-center ProDERM Study PARAMUS, N.J.–(BUSINESS

FDA approves injectable treatment for HIV patients

Outsourcing Pharma

The agency has given the thumbs up to ViiVâs once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV.

FDA Approves Novel Non-Stimulant Treatment for ADHD

BioSpace

FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S.

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

BioTech 365

FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Exelixis Announces U.S. Exelixis Announces U.S.

FDA approval sets stage for a showdown between Alexion and Apellis

Bio Pharma Dive

Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease

FDA Approves Phase II Kidney Cancer Therapy Study

BioTech 365

FDA Approves Phase II Kidney Cancer Therapy Study FDA Approves Phase II Kidney Cancer Therapy Study MELBOURNE, Australia and INDIANAPOLIS, Sept. 14, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States … Continue reading → GlobeNewswire

FDA approves Janssen’s Rybrevant

Pharma Times

First targeted treatment authorised in the US for NSCLC patients with EGFR exon 20 insertion mutations

FDA Approves First Biologic for Rare, Debilitating Lung Disease

BioSpace

FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD The U.S.

FDA approves Blueprint cancer drug for use in rare blood disease

Bio Pharma Dive

The agency's decision makes available a new treatment option for patients with advanced systemic mastocytosis, boosting the biotech in the process

FDA Approves Third Sarepta Treatment For Duchenne Muscular Dystrophy

BioSpace

FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping The U.S.

AstraZeneca lupus treatment Saphnelo obtains FDA approval

BioPharma Reporter

The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.