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FDA Hits Cingulate with CRL for ADHD Tablet, Citing CMC Issues
The letter did not raise any concerns regarding the clinical safety or efficacy of CTx-1301. read more
Madrigal Oral MASH Drug Gets UK Approval
Rezdiffra is the first approved oral treatment for metabolic dysfunction-associated steatohepatitis in both the U.S. and UK. read more
Driving the Data-Rich Future of OSDs
Data-rich, data-led, data-driven — these terms increasingly define modern oral solid dose development. In this roundtable, industry leaders discuss what it will take to navigate this next phase of OSD innovation. read more
Servier Bets $2.65B on Edgewise Muscular Dystrophy Biz
The deal centers around Edgewise’s sevasemten, an investigative orally administered first-in-class fast skeletal myosin inhibitor. read more
BMS Oral CELMoD Candidate More Than Doubles Survival in Multiple Myeloma
Compared to the standard of care, the therapy led to a progression-free survival of 18 months vs. 8.3 months. read more
Shionogi Wins FDA Nod for First Oral Post-Exposure COVID Prevention
Between exposure and day 10, the drug reduced the risk of symptomatic COVID by 67%. read more
FDA Delays Decision on AstraZeneca Oral Breast Cancer Med
The agency is extending the PDUFA date for the company’s camizestrant combination, citing a need to review additional data to support the NDA. read more
Biogen, Denali Axe Parkinson’s Drug After Trial Fail
The LRRK2 inhibitor failed to slow the progression of idiopathic Parkinson’s disease and didn't meet any of the phase 2 trial’s secondary endpoints. read more
Phytolon Closes $23.6M Series B to Advance Beetroot Red Dye
The company offers a natural colorant portfolio, produced via fermentation of baker's yeast. read more
FDA Reshuffles Leadership After Makary Departure
Acting directors of CDER and CBER are both leaving their roles. read more
CapsCanada to Operate as Lyfe Group
The new identity is not the result of an acquisition or merger; it is a strategic step that consolidates the company's operations under one brand. read more
Amgen Partner Reports 20 Liver Injury-Related Deaths in Japan With Possible Link to Vasculitis Drug
Kissei Pharmaceutical has issued a safety alert regarding Tavneos. read more
BeOne Wins First FDA Nod for BCL2 Inhibitor in Mantle Cell Lymphoma
Beqalzi is the first approved BCL2 inhibitor to treat relapsed or refractory mantle cell lymphoma. read more
FDA Puts Hold on Aardvark Prader-Willi Syndrome Drug
Aardvark will be unblinding data from its phase 3 trials to find a way to continue the ARD-101 program. read more
AstraZeneca Wins FDA Nod for Oral Hypertension Drug
Baxfendy reduces systolic blood pressure by inhibiting the production of the hormone aldosterone, lowering the risk for heart and kidney problems. read more
Taiho Gets First FDA Nod for All-Oral AML Regimen
The treatment will be available to newly-diagnosed patients who are ineligible to receive intensive induction chemotherapy or aged 75 years or older. read more
Makary Resigns as FDA Head
According to AP News, Makary resigned under pressure from HHS Secretary Robert Kennedy Jr. and the decision was backed by the White House. read more
FDA Warns of Blood Cancer Risk with Tazverik Tablets
When approved, the incidence rate for SPMs was 1.7%, but a phase 3 trial this year found the risk of SPMs to be 5.7%. read more
Angelini to Buy Catalyst for $4.1B, Entering U.S. Market
The acquisition will give Angelini Pharma the oral drug Firdapse, the only FDA approved treatment for LEMS. read more
CellCentric Raises $220M Series D to Advance Multiple Myeloma Pill
The funds will help advance inobrodib, a first-in-class p300/CBP inhibitor with a completed a phase 2 study. read more

March/April 2026

2026 Annual Buyer’s Guide
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