News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

The failure of Roche’s Ionis-partnered tominersen in Huntington’s disease may indicate that Wave Life Sciences’ allele-specific antisense oligonucleotide candidate WVE-003 is on the right track, according to analysts at Rodman & Renshaw.

Gain the latest insights into the biopharma hiring landscape with BioSpace’s Biopharma Job Market Report Q2 2026. Explore the trends shaping talent acquisition, from rising job postings and sustained R&D hiring to the market activity signaling stronger hiring demand ahead.

As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.

The trials, which were testing the tyrosine kinase inhibitor masitinib, had previously been paused. AB Science’s decision not to resume them was a matter of prioritization, not safety, the biotech said.

The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

CDER proposes to withdraw approval of TAVNEOS

Want to know what’s new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.

The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.

GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates.

The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics.

Roche’s decision to discontinue the Ionis-partnered trials came soon after the biotech sustained a late-stage failure in ATTR-CM.

Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.

The FDA is taking decisive steps to strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and ensure Americans have reliable access to safe, effective, high-quality medicines.

Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.

Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.

The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.

Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.

The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective.

GSK and Alector first partnered in 2021 to advance two antibodies for neurodegenerative diseases. Both assets have since failed to show significant clinical benefit.

An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”

Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile. 

FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC).

After being bought by Bain for $3.3 billion, Tanabe has reached a deal to sell its manufacturing unit and 17 products.

Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.

The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.

In AstraZeneca’s third trip to Asia this year, the pharma secured ex-China rights to a dual inhibitor of PDE3 and PDE4, which in a Phase 2b study significantly improved lung function and lowered symptom burden in patients with chronic obstructive pulmonary disorder.