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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.
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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.
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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%.
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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.
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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.
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FDA Advisory Panel Votes Against AstraZeneca Oral Breast Cancer Med
The Oncologic Drugs Advisory Committee failed to reach a majority vote in favor of the benefit–risk profile of AstraZeneca's camizestrant.
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Cytokinetics Looks to Expand Heart Drug into Non-Obstructive HCM
Already approved for obstructive HCM, Cytokinetics announced positive topline results from a phase 3 trial of aficamten in non-obstructive HCM.
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Novartis to Close German Tablets and Capsules Site
The drugmaker will cut 220 jobs as part of the planned closure of a production site by the end of 2028.
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Arvinas Breast Cancer Nod Marks First FDA PROTAC Approval
Veppanu reduced disease progression and death by 43% compared to fulvestrant.
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Novartis Finalizes U.S. Expansion Plan With Seventh New Facility
The facility will focus on manufacturing APIs for solid dosage tablets and capsules as part of a plan to produce all key medicines within the country.
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J&J to Market Four Drugs on TrumpRx
The drugs include metformin, metformin extended release, Invokana (an SGLT2 inhibitor for type 2 diabetes) and blockbuster Xarelto (a blood thinner).
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Lilly Pens $2.3B Deal for Ajax, Picking Up Oral Blood Cancer Candidate
Ajax's lead candidate is an oral, Type II JAK2 inhibitor that uses a unique mode of binding for potentially deeper and more durable disease control.
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FDA Approves Merck Once-Daily HIV Pill
Idvynso demonstrated non-inferior efficacy compared to the three-drug regimen in a phase 3 trial.
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Novo to Seek Approval of Oral GLP-1s to Treat T2 Diabetes in Kids
If approved, the drug will be the first oral GLP-1 RA that provides superior glycemic efficacy in pediatric patients with T2 diabetes.
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Trump Signs Order to Fast Track Psychedelic Drugs for Mental Health Treatment
Three psychedelic drugs will receive national priority vouchers from the FDA next week.
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BioAge Oral Inflammation Drug Cuts Heart Risks in Trial
The phase 1 trial led to median hsCRP reductions of more than 85% when patients took daily doses.
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Kailera Sets IPO Record, Raising $625M for Obesity Drugs
Among its most promising drugs is oral ribupatide, a once-daily pill entering phase 3 trials in China.
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Dr. Erica Schwartz Nominated as New CDC Director
Schwartz, an ex deputy surgeon general, will take over the role if she receives Senate approval, which could take months.
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Travere Gets Landmark FDA Approval in Rare Kidney Disease
The FDA has granted full approval to Filspari to reduce proteinuria in focal segmental glomerulosclerosis without nephrotic syndrome.
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Peptide-to-Small-Molecule Translation
Recent advances are turning what was once a trial-and-error exercise into a disciplined and reproducible design workflow.
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CURRENT ISSUE
May/June 2026
2026 Annual Buyer’s Guide
2026 Annual Buyer’s Guide
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