Bristol Myers Squibb drug Augtyro now has a tumor-agnostic approval permitting the drug to be used to treat all solid tumors positive for NTRK gene fusions. Augtyro came from BMS’s $4.1 billion acquisition of Turning Point Therapeutics.

The post New FDA Nod Brings Bristol Myers Squibb Cancer Drug to a Wider Range of Solid Tumors appeared first on MedCity News.

The Supreme Court sided with the FDA and unanimously ruled to uphold access to abortion pill mifepristone. The decision quells worries about what it might look like if the Supreme Court sided with the physician group — many healthcare leaders feared that if the top court could overturn mifepristone’s FDA approval, the same could happen to other drugs.

The post How Healthcare Leaders Are Reacting to the Supreme Court Preserving Abortion Pill Access appeared first on MedCity News.

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer.

The post Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease appeared first on MedCity News.

Geron Corporation’s Rytelo is now FDA approved for treating anemia caused by myelodysplastic syndromes. The new drug will compete against Reblozyl, a blockbuster Bristol Myers Squibb medicine.

The post Geron Drug Lands a First-in-Class FDA Approval in Type of Blood Cancer appeared first on MedCity News.

Medical device company Zeto received clearance for its EEG brain monitoring system. The system includes a user-friendly, comfortable EEG headset designed to be easily operated by any medical professional with minimal training.

The post Zeto Receives FDA Clearance for Its User-Friendly EEG Brain Monitoring System appeared first on MedCity News.

Three upcoming Supreme Court decisions have the potential to radically change FDA regulation of medications.
The cases, which involve “Chevron deference” and the abortion pill mifepristone, were discussed on a panel during the BIO conference in San Diego.

The post Why a SCOTUS Ruling on Fishing Rules Could Change How FDA Regulates Drugs appeared first on MedCity News.

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year.

The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

If Medicare acts, the potential of AI-enabled technologies to improve healthcare outcomes for patients, regardless of their geographic location or socioeconomic status, will be closer to being fully realized.

The post Making Access to AI-enabled Medical Devices Equitable for All appeared first on MedCity News.

Abbott earned FDA approval for its dissolving stent designed to unclog arteries below the knee. This marks the first time the FDA has approved a stent or drug-coated balloon to help arteries stay open below the knee.

The post Abbott Earns FDA Approval For Dissolving Stent That Unclogs Arteries Below The Knee appeared first on MedCity News.

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary.

The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder.

The post Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B appeared first on MedCity News.

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.

The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells.

The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News.

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder.

The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.

The post AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med appeared first on MedCity News.

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.

The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.

The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It? appeared first on MedCity News.

The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.

The post AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval appeared first on MedCity News.

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

The post Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug appeared first on MedCity News.

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma.

The post Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval appeared first on MedCity News.

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.

The post FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease appeared first on MedCity News.

Orchard Therapeutics gene therapy Lenmeldy won FDA approval for treating the rare enzyme deficiency metachromatic leukodystrophy. In January, Kyowa Kirin completed its acquisition of Orchard, which now operates as a subsidiary of the Japanese drugmaker.

The post Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder appeared first on MedCity News.

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

The post A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug appeared first on MedCity News.

The FDA approved BeiGene’s Brukinsa as a treatment for advanced cases of follicular lymphoma. It’s the fifth FDA nod for the drug, which has become BeiGene’s top-selling product.

The post Blockbuster BeiGene Cancer Drug Adds Another FDA Approval appeared first on MedCity News.

This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.

The post An Attack on Patients’ Right to Informed Consent appeared first on MedCity News.

Sandoz drugs Jubbonti and Wyost are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies.

The post FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs appeared first on MedCity News.

FDA’s regulation of single-use device reprocessing effectively made the U.S. the leader in EP sustainability efforts early on. However, very little has been done to build on this early leadership.

The post Is Europe About to Overtake the U.S.’s Leadership Position in Healthcare Sustainability via Reprocessing? appeared first on MedCity News.

The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

The post Adverse Event Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma appeared first on MedCity News.

Iovance Biotherapeutics’s Amtagvi is now the first FDA-approved treatment based on type of cell called a tumor-infiltrating lymphocyte. The regulatory nod in advanced melanoma also makes Amtagvi the first cell therapy approved for treating a solid tumor.

The post FDA Approves Iovance Cancer Treatment, the First Cell Therapy for a Solid Tumor appeared first on MedCity News.

Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.

The post FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves appeared first on MedCity News.