Regulatory approval Archives

News and Trends 28 Jul 2022

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

A drug to target a rare genetic form of a neurological disease that affects the nerve cells, leading to the loss of everyday functions, could be the first of its kind available if approved. The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Massachusetts-based Biogen Inc. for tofersen, an […]

July 28, 2022 - 4 minutesmins - By Liza Laws

geneuro multiple sclerosis neuron viral dna

News and Trends 18 Jul 2022

First-ever Marketing Authorization Application for biosimilar targeting MS filed

An international biotech, with headquarters in Amsterdam, has announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for its biosimilar product. Polpharma Biologics, which is dedicated to the development of biosimilars, announced on Friday (July 15) that natalizumab, similar to Tysabri, which treats multiple sclerosis, has been accepted as […]

July 18, 2022 - 3 minutesmins - By Liza Laws

News and Trends 27 Jun 2022

Covid vaccine granted marketing authorization in Europe

Specialty vaccine company, Valneva, has been given marketing authorization in Europe for its inactivated whole-virus COVID-19 vaccine VLA2001. This is a turnaround from the company’s situation in May of this year when the stock price was knocked down by 20% when gaining traction in the EU was proving to be a struggle. Despite authorization from […]

June 27, 2022 - 3 minutesmins - By Liza Laws

News and Trends 20 Apr 2022

Valneva’s Covid-19 Vaccine Reaches UK Market with EU In Sights

A Covid-19 vaccine developed by the French company Valneva has received the green light from the UK’s drug regulator. The EMA, meanwhile, is proving harder to convince. The UK’s relationship with the French vaccine developer Valneva has run hot and cold over the past two years. In 2020, the UK government invested in Valneva’s manufacturing […]

April 20, 2022 - 4 minutesmins - By Jonathan Smith

Cultured meat Europe cellular agriculture

In Depth 13 Apr 2022

Cultured Meat Is Coming Soon: Here’s What You Need to Know

Cultured meat promises to change the way we eat and help solve some of the big problems of a crowded planet. When will it be on our plate and how will this technology impact the world? In a couple of years, your food might be served with meat that has been grown from animal cells […]

April 13, 2022 - 12 minutesmins - By Clara Rodríguez Fernández

Best in Biotech 22 Dec 2021

The Biggest European Biotech News of 2021

In spite of the challenges posed by the Covid-19 pandemic, the European biotech industry has emerged stronger than ever this year. These were the key moments for the sector in 2021. The year 2021 has seen skyrocketing fortunes for many European biotech players. Investment firms, for instance, raised far more funding than in 2020, which […]

December 22, 2021 - 10 minutesmins - By Jonathan Smith

argenx efgartigimod treatment autoimmune disease myasthenia gravis

News and Trends 21 Dec 2021

Argenx’s Potential Blockbuster Gets FDA Nod for Autoimmune Disease

US regulators have approved the first-in-class drug efgartigimod for the treatment of the rare muscle disease generalized myasthenia gravis, opening up its developer argenx to billion-dollar revenues. Efgartigimod, to be marketed as Vyvgart, is an antibody fragment drug for use in adults with generalized myasthenia gravis. The FDA’s decision represents the first successful drug approval […]

December 21, 2021 - 4 minutesmins - By Anita Chakraverty

growth hormone deficiency ascendis pharma

News and Trends 1 Sep 2021

Slow-Release Jab for Child Growth Hormone Deficiency Gets FDA Nod

The FDA has given the green light to Danish company Ascendis Pharma for the first slow-release formulation that provides a weekly alternative to daily injections for children with growth hormone deficiency. For decades, patients with growth hormone deficiency have required tedious daily hormone injections to stave off the effects of the rare condition, including slow […]

September 1, 2021 - 5 minutesmins - By Jonathan Smith

News and Trends 14 Jul 2021

EMA Market Approval Rate for Small Biotechs Skyrocketed Last Year

The success rate for small biotechs applying for regulatory approval from the EMA has risen by over 100% since 2016, which analysts partly attribute to increased access to sophisticated technology and funding. According to a recent announcement from the EMA, the regulator greenlit a whopping 89% of applications for marketing authorization for new medicines from […]

July 14, 2021 - 3 minutesmins - By Victor Kotsev

News and Trends 17 Jun 2021

FDA Approval of Biogen’s Drug Boosts European Alzheimer’s Space

The FDA shocked many life sciences observers by greenlighting Biogen’s treatment candidate for Alzheimer’s last week. Yet, for much of the Alzheimer’s disease community on both sides of the Atlantic, the decision also brings cautious hope. Controversy recently erupted when the FDA conditionally granted accelerated approval to Biogen’s aducanumab, making it the first approved treatment […]

June 17, 2021 - 6 minutesmins - By Victor Kotsev

News and Trends 20 May 2021

EU Approves Edible Insects for Humans but Roadblocks Remain

Europe is seeing a surge of interest in edible insect farming after an EU vote earlier this month greenlit the first insect-derived food product for human consumption. But insect protein pioneers still face other obstacles such as restrictions on what insects can be fed. The approval went to dried yellow mealworm developed by French-based biotech […]

May 20, 2021 - 6 minutesmins - By Anita Chakraverty

News and Trends 11 May 2021

ADC Approval Buoys Spirits in Cancer Treatment Space

The FDA recently approved an antibody-drug conjugate drug from ADC Therapeutics as a treatment for blood cancer. This has given a major confidence boost to other European companies in the field as the deal mill picks up speed. Last month, ADC Therapeutics in Switzerland broke into the mainstream when its lead candidate Zynlonta received FDA […]

May 11, 2021 - 7 minutesmins - By Jonathan Smith

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Regulatory approval

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

First-ever Marketing Authorization Application for biosimilar targeting MS filed

Covid vaccine granted marketing authorization in Europe

Valneva’s Covid-19 Vaccine Reaches UK Market with EU In Sights

Cultured Meat Is Coming Soon: Here’s What You Need to Know

The Biggest European Biotech News of 2021

Argenx’s Potential Blockbuster Gets FDA Nod for Autoimmune Disease

Slow-Release Jab for Child Growth Hormone Deficiency Gets FDA Nod

EMA Market Approval Rate for Small Biotechs Skyrocketed Last Year

FDA Approval of Biogen’s Drug Boosts European Alzheimer’s Space

EU Approves Edible Insects for Humans but Roadblocks Remain

ADC Approval Buoys Spirits in Cancer Treatment Space

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Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

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