FDA approval

The FDA’s Dec. 30 approval of Vanda Pharmaceuticals’ Nereus (tradipitant) adds a rare new option to a category that has leaned for decades on older anticholinergics and antihistamines, including the scopolamine patch and over-the-counter products such as meclizine and dimenhydrinate. In reporting on the decision, Reuters noted the approval as the first new FDA-cleared treatment…

Neisseria gonorrhoeae, the bacterium that causes the sexually transmitted disease (STD) gonorrhea, has developed resistance to many of the antibiotics that are used to treat it. Most patients with gonorrhea take a drug called ceftriaxone, a third-generation cephalosporin antibiotic, but resistance to that is growing.  Recently, doctors have found two potential antibiotics that could treat…

The FDA approved Lynkuet (elinzanetant) 60 mg capsules for the treatment of moderate to severe hot flashes due to menopause last week. Lynkuet is reportedly the first and only dual neurokinin (NK) targeted therapy, as it is both a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist.  Filling the gap of nonhormonal treatment options…

The FDA has granted simultaneous approval for HERNEXEOS (zongertinib tablets), developed and commercialized by Boehringer Ingelheim, for the treatment of adult patients with non-small cell lung cancer (NSCLC). The approval covers tumors with HER2 (ERBB2) activating mutations. It also signed off on Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to…

In drug discovery, the difference between a breakthrough and a breakdown can be as small as the twist of a bond. Stereochemistry, the three-dimensional arrangement of atoms, governs how otherwise identical molecules behave in the body: whether they bind the intended target, trigger off-targets, or get cleared in minutes rather than hours. “Shape really does…

Novo Nordisk’s $5.2 billion acquisition of Akero Therapeutics sits at the center of 2025’s hottest M&A space: MASH/metabolic disease. The deal, announced October 9, represents the largest of three major Fibroblast Growth Factor 21 (FGF21) analog acquisitions in five months. Across the broader landscape, 2025 pharma M&A activity reached approximately $70 billion in upfront consideration…

Pfizer Inc. and BioNTech SE announced today that the FDA has approved their COVID-19 vaccine for adults ages 65 and older and individuals from 5 to 64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.  The approval comes amidst the development of a…

Dr. Katie Abouzahr, Johnson & Johnson’s new head of late-stage immunology development, draws on her NHS clinical roots and 11 years at Boston Consulting Group to tackle drug R&D’s most complex challenges. Having recently stepped into the role about a month ago, she oversees a portfolio that includes the newly FDA-approved nipocalimab for myasthenia gravis,…

Precision medicine promises the “right drug, right patient” mantra. One piece that sometimes goes missing? A test approved on day one. Jane Li has spent two decades making sure that gap closes on schedule. As senior director of pharma CDx and CRO partnerships at Thermo Fisher Scientific, she has an important role in this complex…

In 2024, we saw the expanded use of synthetic data and natural language processing transform drug discovery and development. In a batch of predictions published in December of 2023, one expert predicted that synthetic data was set to “take off” in drug research. In 2025, the pendulum could begin swinging back the other way, according…

The recent FDA approval of Lilly’s Kisunla (donanemab) represents a significant win in Alzheimer’s drug development, a field that has seen a  decades of false starts and fizzled hopes. This approval, along with that of lecanemab in 2023, could mark a turning point in AD treatment. Alzheimer’s disease is reaching epidemic proportions with an estimated…

Moderna’s mRESVIA (mRNA-1345) has become the first mRNA-based vaccine for respiratory syncytial virus (RSV) to receive FDA approval. The vaccine is indicated for the prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. This milestone marks Moderna’s second FDA-approved product after its COVID-19 vaccine. Earlier this year,…

Pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening blood vessel disorder, affects some 500 to 1,000 new patients each year in the U.S. FDA recently approved Opsynvi, a first-of-its-kind once-daily single-tablet combination therapy from Johnson & Johnson. “With this approval, our portfolio now includes treatments that address all three guideline-recommended pathways,” said a J&J…

The recent FDA approval of a cardiovascular risk reduction indication for Wegovy (semaglutide) could point toward a significant opportunity for pharma companies seeking to reshape payer perceptions and expand coverage for next-gen metabolic therapies. This regulatory shift, allowing Wegovy to be prescribed for reducing the risk of major adverse cardiovascular events such as heart attack…

Semaglutide was already one of the best-selling drugs of recent memory. And Novo Nordisk the fastest-growing Big Pharma firm. Now, the FDA’s decision to expand the label of its weight-loss version of the drug to include cardiovascular benefits could help unlock more growth momentum for Novo Nordisk. This positions Wegovy as the first weight-loss medication…

A once-controversial psychedelic substance could potentially be a promising treatment for generalized anxiety disorder (GAD). That’s the view of Dr. Rakesh Jain, a psychiatrist with extensive experience in clinical practice, research, and education, affiliated with Texas Tech University School of Medicine. Jain expressed optimism in LSD-based therapy while acknowledging the challenges inherent in such a…

The story of Aduhelm has been rocky now for years. Biogen turned heads when its controversial Alzheimer’s therapy won accelerated approval from the FDA against the advice of its own advisory panel in mid-2021. The company had high hopes for the antibody at that point, pricing it at an average of $56,000 per year. Aduhelm…

Founded in 2011, Caribou Biosciences is a pioneer in the development of CRISPR genome editing technologies, a field honored with the Nobel Prize in Chemistry in 2020. Co-founded by Jennifer Doudna, Ph.D., one of the Nobel laureates, and CEO Rachel Haurwitz, and two other CRISPR pioneers, the company has raised over $800 million in funding,…

Repurposing is a drug development strategy that has been widely applied in cancer. This strategy, sometimes called label expansion, involves obtaining FDA approval to market a drug for the treatment of new indications, alone or in combination with other drugs. Not only can this approach extend the window of patent protection for a commercialized drug,…

MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks. On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress…

With promising interim phase 2 data in hand, Cybin believes psychedelic therapy will become a reality in the “not too distant future,” according to CEO Doug Drysdale. As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But…

Lilly’s tirzepatide notched an FDA approval for chronic weight management, potentially clearly the way for billions in additional sales. Analysts have projected that the drug could fetch $26 billion in annual sales by 2030, with roughly two-thirds of that sum related to obesity​ treatment​. Bank of America analyst Geoff Meacham is even more optimistic, predicting…

Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV,…

GSK (NYSE:GSK) is aiming to expand the label for its respiratory syncytial virus (RSV) vaccine Arexvy, which was the first to win FDA approval. The firm is now eyeing an extension of the label to include adults aged 50 to 59, bolstered by encouraging preliminary data from a phase 3 study. The recent data from…

2023 is shaping up to be a blockbuster year for Eli Lilly. With the company’s stock soaring by almost 54% since the beginning of the year, analysts are largely upbeat about Lilly’s expanded focus on obesity and diabetes treatments. While the company has developed insulin for a century, the company is now broadening its horizons…