Industry News
Pharmaceutical Industry News
Un fármaco común para perder peso puede tratar una enfermedad hepática grave, según la FDA
Se ha aprobado el uso de Wegovy entre el creciente número de estadounidenses que padecen una enfermedad hepática asociada a una disfunción metabólica.
Wegovy Gets F.D.A. Approval for MASH
Wegovy has been approved for use among the growing number of Americans who have MASH.
Roche has found redemption in a…
Roche has found redemption in a precision medicine approach following an earlier Tecentriq trial flop in a broader bladder cancer population.
An appeals court overturned a…
An appeals court overturned a prior FDA action in a years-long face-off between Vanda and the agency over a delayed hearing for Vanda's jet lag disorder hopeful Hetlioz.
Several months after unveiling its…
Several months after unveiling its direct-to-consumer NovoCare Pharmacy service with the launch of a $499 cash-pay option for a monthly supply of Wegovy, Novo Nordisk is expanding the discount to its other GLP-1 heavyweight.
Sarepta Therapeutics has provided…
Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy patient group petitions the FDA to update the medicine’s label.
The FDA has signed off on an…
The FDA has signed off on an accelerated approval for Novo Nordisk's Wegovy to treat certain adults with metabolic-associated steatohepatitis. The green light tees up a likely showdown with Madrigal Pharmaceuticals' approved drug Rezdiffra in
China’s Biotech Is Cheaper and Faster Than America’s
China’s biotechnology sector has established a bright future by focusing not on breakthrough cures and treatments but on speed and efficiency.
Tonix Pharmaceuticals was founded…
Tonix Pharmaceuticals was founded in 2010 to develop and bring to market a drug for fibromyalgia. Fifteen years later, the New Jersey company has accomplished its mission with an FDA sign-off for Tonmya.
Earlier this summer, HHS Secretary…
Earlier this summer, HHS Secretary Robert F. Kennedy ousted all members of the CDC's vaccine advisory committee in an effort to remove industry influence. But according to a new study, industry-related conflicts of influence had
Every year, Fierce celebrates…
Every year, Fierce celebrates women making a powerful impact across biopharma and medtech. It’s time once again to make your suggestions for this year’s honorees.
The CDMO, formerly known as Oxford…
The CDMO, formerly known as Oxford Biomedica, sold more than 12.2 million ordinary shares for £4.31 ($5.85) per share. In addition, existing shareholders subscribed for 1.7 million shares at the same price, the company said.
After a 54% year-over-year sales…
After a 54% year-over-year sales increase for CGRP migraine drug Vyepti in the U.S., Lundbeck has raised its peak sales projection for the therapy in the key market.
Nearly a year after earning the…
Nearly a year after earning the first-ever FDA approval for a self-administered flu vaccine, AstraZeneca has kicked off a new service delivering its FluMist directly to consumers.
U.S. District Judge Gregory…
U.S. District Judge Gregory Williams concluded that two patents held by Lindis Biotech “are unenforceable due to inequitable conduct.” The decision negates the $50.3 million jury verdict Lindis won in December over allegations that Amgen’s
The FDA has approved a treatment…
The FDA has approved a treatment for recurrent respiratory papillomatosis for the first time. The agency has signed off on Precigen’s Papzimeos, a non-replicating adenoviral vector-based immunotherapy, which can eliminate the need for repeated surgical
The combination of Padcev and…
The combination of Padcev and Keytruda delivered a phase 3 win in muscle-invasive bladder cancer. China did not renew the conditional approval for a controversial Alzheimer's disease drug. Fosun Pharma is out-licensing its DPP1 inhibitor
Trump’s Tariffs Set to Hit Ireland, Where Drugmakers Play Tax Games
Manufacturing in Ireland has long helped many American drug companies pay lower taxes. But that strategy was designed for a world without President Trump’s tariffs.
While Sanofi originally had its…
While Sanofi originally had its eye on tolebrutinib when it purchased its partner Principia Biopharma for $3.7 billion, another of the biotech’s BTK inhibitors has made it across the FDA finish line first.
Eli Lilly said it has “intensified…
Eli Lilly said it has "intensified efforts to align prices across developed countries" in recent months. Besides a new U.K. price hike, Lilly said it may make other "necessary pricing adjustments" by Sept. 1.