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

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

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 approval for Xywav for idiopathic hypersomnia in adults

Pharma Times

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

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

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

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

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

Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

BioTech 365

Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000 Enables expansion of recruitment into ongoing phase I study to include eligible US patients … Continue reading → Business Wire

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.

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 Multiple Investigational New Drug Applications

BioSpace

This week, the U.S. Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development

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.

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 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.

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

Sarepta wins FDA approval of another drug for rare muscular dystrophy

Bio Pharma Dive

Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed

Luminopia scores FDA approval for TV-based amblyopia therapy

Pharma Phorum

Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows.

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 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 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.

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 Virtual Reality Pain Treatment

XTalks

Virtual reality pain therapy company AppliedVR bagged de novo clearance from the US Food and Drug Administration (FDA) this week for its virtual reality EaseVRx system indicated as an adjunct treatment for chronic lower back pain for patients 18 years of age and older.