Industry News

Pharmaceutical Industry News

The FDA has signed off on an…

August 18th, 2025|Fierce Pharma|

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

Tonix Pharmaceuticals was founded…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 15th, 2025|Fierce Pharma|

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…

August 14th, 2025|Fierce Pharma|

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

While Sanofi originally had its…

August 14th, 2025|Fierce Pharma|

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…

August 14th, 2025|Fierce Pharma|

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.

An analysis of how cancer…

August 14th, 2025|Fierce Pharma|

An analysis of how cancer drugmakers interact with oncologists found, perhaps unsurprisingly, that those interactions are dominated by therapies boasting a broad reach and targeting the most common cancers.

Despite a threat from President…

August 14th, 2025|Fierce Pharma|

Despite a threat from President Donald Trump early last week that the administration's policy on pharmaceutical tariffs would come “within the next week or so,” his much-anticipated announcement is still “weeks away,” Reuters reports.

Chinese authorities did not renew…

August 14th, 2025|Fierce Pharma|

Chinese authorities did not renew a conditional approval of Green Valley Pharmaceuticals’ controversial Alzheimer’s disease drug sodium oligomannate, also known as GV-971, according to online records.

President Donald Trump has inked a…

August 14th, 2025|Fierce Pharma|

President Donald Trump has inked a new executive order calling on the HHS’ Administration for Strategic Preparedness and Response to identify and stockpile active pharmaceutical ingredients for roughly 26 medicines the agency deems essential.

Sana Biotechnology will turn to…

August 14th, 2025|Fierce Pharma|

Sana Biotechnology will turn to CDMOs for manufacturing and pause its plant build-out in Bothell, Washington. The company opened the facility a year ago.

As it continues development of its…

August 13th, 2025|Fierce Pharma|

As it continues development of its rademikibart for asthma and other inflammatory diseases, Connect Biopharma is teaming up with former pro football player Elbert “Ickey” Woods to drive asthma awareness across the U.S.