Industry News
Pharmaceutical Industry News
A campaign backed by Kyowa Kirin,…
A campaign backed by Kyowa Kirin, Amgen and Sanofi is calling on prominent organizations with medical websites to bring their resources on women and girls with X-linked conditions up to date.
The FDA has begun accepting…
The FDA has begun accepting applications for a priority pathway designed to slash review times to one to two months, giving developers of medicines that align with U.S. national health priorities a fast track to
AstraZeneca Joins Pharma Investment Push in U.S. Amid Tariff Threat
The U.K.-based drugmaker plans to invest $50 billion in the United States as the industry seeks to appease President Trump.
Prescription brands are winning at…
Prescription brands are winning at awareness but losing at the pharmacy counter. Learn how GoodRx helps brands convert where it matters most.
An early July post on the TikTok…
An early July post on the TikTok account for Evofem Biosciences’ Phexxi birth control has sparked a surge in interest in the nonhormonal gel without even talking about the product—and perfectly sums up the brand’s
A Delaware jury has agreed with…
A Delaware jury has agreed with AbbVie’s claim that in creating a rival treatment for Botox, Revance Therapeutics infringed on three patents covering the formulation and manufacturing process of the mega-blockbuster. With the verdict, the
Avalyn Pharma has added on $100…
Avalyn Pharma has added on $100 million to accelerate novel inhaled versions of approved drugs for lung conditions.
A brief skirmish between Sarepta…
A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand.
As GSK prepares to move production…
As GSK prepares to move production work on a vaccine asset to Pennsylvania, 150 employees at GSK’s Binney Street site in Cambridge, Massachusetts, are set to be laid off, according to a Worker Adjustment and
First Pill for Postpartum Depression Shows Varied Real-World Results
Some women’s symptoms improved quickly after taking the pill, but depression persisted in others. Doctors are trying to learn which patients benefit, and why some don’t.
The PMCPA ruled that “a systemic…
The PMCPA ruled that “a systemic failure in compliance oversight” at Theramex has brought discredit on the industry, prompting the U.K. pharma marketing watchdog to consider additional sanctions against the company.
Boehringer Chief Medical Officer…
Boehringer Chief Medical Officer Lykke Hinsch Gylvin, M.D., set out the German drugmaker's plans to launch into 20 indications in the coming years.
F.D.A. Panel Debates ‘Black Box’ Warning for Antidepressants in Pregnancy
An agency-sponsored forum included critics of psychiatry who believe the drugs can harm a developing fetus. Other experts said antidepressants were safe and necessary.
Sarepta Refuses FDA Request to Stop Shipping Muscular Dystrophy Drug Elevidys
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.
Heath Insurers Are Denying More Drug Claims, Data Shows
Offering a rare glimpse inside the hidden world of rejected insurance claims, new data shows a steady uptick among major private insurers.
Trump Administration’s N.I.H. and F.D.A. Cuts Could Curtail New Drug Development, Budget Office Says
The Trump administration’s proposed cuts to medical research and health agencies will curtail the development of promising medications, the Congressional Budget Office said on Friday.
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments
Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated.
South African AIDS Activist Pushes for H.I.V. Treatment Access After U.S.-Aid Cuts
Zackie Achmat, once at the center of South Africa’s push for lifesaving H.I.V. treatment, has come out of retirement as U.S. funding cuts and his own government’s inertia revive old fears.
F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs. All eventually passed muster.
Inside the Collapse of the F.D.A.
How the new health secretary, Robert F. Kennedy Jr., is dismantling the agency.